CD HORIZON SOLERA

Spinal System
® ™

Surgical Technique
The CD HORIZON® SOLERA™ System is the first
platform technology that enables surgeons
to confidently and efficiently treat their patients
by using:
» high strength, low profile multi-axial screws
designed for use with multiple rod types1
» the first-ever powered instruments being
developed specifically for spinal implants*
» minimally invasive techniques, navigation tools,
and advanced reduction technology that are
compatible with the system
» implant traceability enhanced with inventory
and billing management

Intended for Surgical Assessment Participants Only.

1Based on internal testing per ASTM F1798 (internal test report TR09-312).
Test not indicative of human clinical outcome.
*POWEREASE™ Powered Instruments are designed for procedural steps like rod
and post cutting and final construct tightening and are not currently available.
CD HORIZON ® Technology Overview 2
Implant Features 3

SOLERA™
Spinal System
Hook Implants
Instrument Overview
Instrument Set
5
6
7
Pedicle Screw Surgical Technique
Surgical Technique Thoracic Facetectomy and Starting Points
Screw Starting Points
17
18
Pedicle Preparation 19
Enabling Technologies 21
VERIFYI™ Implant Tracking 22
Screw Placement 23
Rod Contouring and Placement 24
Rod Reduction 25
Sequential Reduction 27
Deformity Correction 29
Final Tightening and Decortication 31
CD HORIZON® X10 CROSSLINK® Plate Placement 32
Postoperative Care and Mobilization 35
Explantation 36
Hook Surgical Technique
Surgical Strategy 38
Hook Site Preparation, Options, and Insertion 39
Hook Site Preparation, Options, and Placement 40
Decortication 44
Rod Contouring 45
Rod Insertion 46
Deformity Correction 47
Compression and Distraction 49
Stabilization and Holding Rod Placement 50
Final Tightening 51
CD HORIZON® X10 CROSSLINK® Plate Placement 52
Closure 52
Explantation 52
Product Ordering Information 53
Important Product Information 57
2 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Technology Overview

Small profile implant

with a Cobalt Chrome
head and a dual
lead OSTEOGRIP®
thread form

Compatible with
Mini-open and
POWEREASE® Powered Instruments
navigation-assisted
being developed specifically for
minimally invasive
spine surgery*
approach options

CD HORIZON®
SOLERA™
Spinal System

Compatible with advanced

instrumentation designed
specifically for complex
spine cases

VERIFYI™ System tracks

actual OR implant use by
lot and part number
Intraoperative
flexibility to change
rod material type

*POWEREASE™ Powered Instruments are designed for procedural steps like rod
and post cutting and final construct tightening and are not currently available.
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 3

Implant Features
From the thoracic spine to the ilium, the CD HORIZON® SOLERA™ Spinal System
facilitates surgeon choice and flexibility across patient types with a variety of implant
options for treating multiple spinal pathologies with one system. With its 4.75mm
rod diameter, the system offers the opportunity to reduce the overall metal mass
and implant profile without compromising construct integrity, as compared to
CD HORIZON® LEGACY™ System 5.5mm Stainless Steel constructs.1 The technology
platform offered with this system is backed by more than 25 years and 400,000 cases
of CD HORIZON® clinical experience and Medtronic expertise.
Multi-Axial Screw

»» Dual lead OSTEOGRIP® thread form

»» Smaller Profile—26% reduction in overall volume than
CD HORIZON® LEGACY™ 5.5mm Multi-Axial Screw and 12% smaller than
CD HORIZON® LEGACY™ 4.5mm Multi-Axial Screw
»» Cobalt Chrome head is compatible with CD HORIZON® CHROMALOY™,
CD HORIZON® CHROMALOY™ Plus, and Titanium Rods, allowing real-time rod
choices in the OR to customize the stiffness and strength of the construct
»» Imaging comparable to Titanium screw heads2
»» Color-coded by bone screw diameter

Fixed Angle Screw

»» Dual lead OSTEOGRIP® thread form

»» Smaller Profile—21% smaller than CD HORIZON® LEGACY™ System 5.5mm
Fixed Angle Screw
»» Color-coded by bone screw diameter
»» Compatible with CD HORIZON® CHROMALOY™, CD HORIZON® CHROMALOY™
Plus, and Titanium Rods, allowing real-time rod choices in the OR to customize
the stiffness and strength of the construct

Break-off Set Screw

»» Internal TORX for secure instrument engagement

»» Features a quick start thread with a blunt start cut
»» Design does not allow for misaligned set screws to fully engage or provide
break-off feedback when used in multi-axial screws3

1Based on internal testing of a CD HORIZON® CHROMALOY™ Plus rod construct, per ASTM F1717 (internal test report TR04-269 and TR09-313).
Testing not indicative of human clinical outcome.
2
Results based on internal testing in a cadaveric model (internal test report TR10-184). MRI and CT images were taken of constructs of three
different materials: Stainless Steel, Titanium, and Cobalt Chrome. Images were reviewed by seven technical experts for clarity in regions of interest.
3
Based on internal testing (internal test report TR10-219).
4 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Implant Features continued

Rod Spectrum

»» Multiple material types for intraoperative flexibility

CD HORIZON® CHROMALOY™ Plus Rod »» Available rods

- Straight, lined Titanium Alloy Rod
Titanium Alloy Rod - Straight CD HORIZON® CHROMALOY™
and CD HORIZON® CHROMALOY™ Plus Rod
- Precontoured and Precut
CD HORIZON® CHROMALOY™ Rod CD HORIZON® CHROMALOY™ Rod

CD HORIZON® X10 CROSSLINK® Plate

»» Compatible with CD HORIZON® CHROMALOY™,

CD HORIZON® CHROMALOY™ Plus, and Titanium Rods
»» Adjustable or fixed length and angulation
»» Attaches to the rod in the coronal, sagittal, or
transverse planes in any orientation

Hooks

»» Compatible with CD HORIZON® CHROMALOY™,

CD HORIZON® CHROMALOY™ Plus, and Titanium Rods
»» Anatomic angulation to mimic the posterior
spinal elements
»» Centralized head for balance

Lateral Connectors

»» Compatible with CD HORIZON® CHROMALOY™,

CD HORIZON® CHROMALOY™ Plus, and Titanium Rods
»» Medial/lateral adjustability may prevent the need for
coronal rod bending

Iliac Screws*

»» Closed fixed head iliac screws available in 0°, 10°, and 20°
angles
»» Closed Multi-Axial Screws (CMAS) provide flexibility to
position the screw head

*Lateral Connectors must be used with CD HORIZON® System Iliac Screws.

 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 5

Hook Implants

Vertebral Posterior Blade Region

Hook Type Design Features
Element Placement Direction of Spine

» Bifid blade grasps thoracic

Pedicle Hook Articular Process T1 – T10
pedicle for stability.

Lamina T1 – L5 » Wider blade width distributes

forces evenly over a wider
Wide Blade Hook
aspect
Transverse Process T1 – L5 of bone.

Lamina T1 – L5 » Narrower blade width

Narrow Blade Hook minimizes metal volume
in the spinal canal.
Transverse Process T1 – L5

Lamina T1 – L5
Wide Blade » Ramp reduces
Ramped Hook intra-canal intrusion.
Transverse Process T1 – L5

Lamina T1 – L5
Narrow Blade » Ramp reduces
Ramped Hook intra-canal intrusion.
Transverse Process T1 – L5

Lamina T1 – L5 » Can correct anatomic

Extended Body misalignment between two
Hook laminae in the
Transverse Process T1 – L5 dorso-ventral plane.

Lamina T1 – L5 » Centralized head for balance.

Offset Hook » Anatomic angulation

to mimic the posterior
Transverse Process T1 – L5 spinal elements.

» Centralized head for balance.

» Lipped design can
Total Anatomical improve hook stability.
Articular Process T1 – T10
Pedicle Hook
» Anatomic angulation
to mimic the posterior
spinal elements.
» Centralized head for balance.
» Lipped design can
Total Anatomical
improve hook stability.
Transverse Process Transverse Process T1 – L5
Hook » Anatomic angulation
to mimic the posterior
spinal elements.

Color-coding Size Reference

Extra Small Small Medium Large

6 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Instrument Overview
Sequential Reducer Rod Gripper

Attaches firmly
to the rod for
controlled rod
manipulation.

Allows controlled and

sequential rod reduction.

Hinged Translator Dual Ended Set Screw Starter

Engages inner set

screw torx for better
Compresses and
visualization, and the
distracts off of the
knurled grip enhances
rod, not the implant.
tactile feel compared
to previous designs.

Adjustable Handle

Allows easy attachment

to drivers and shafts for
OR efficiency.
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 7

Instrument Set
Screw Preparation

Thoracic Probe Lumbar Probe

8350294 8350293

In-Line Handle Round Awl Modified Quick Connect Ratcheting

7480104 Handle
9339082

Quick Connect
Ratcheting T-Handle
7579000

Dual Ended Feeler Probe

7480100

Sounding/Feeler Probe, 2mm

8572102

Taps
8350420 (3.75mm) 8350425 (6.0mm)
8350421 (4.0mm) 8350426 (6.5mm) Straight Holt Probe
8350422 (4.5mm) 8350428 (7.5mm) 803-292
8350423 (5.0mm) 8350430 (8.5mm)
8350424 (5.5mm) 8350432 (9.5mm)

T-handle Holt Probe

803-290
Screw Placement

Fixed Angle Screwdriver Lock Sleeve Multi-Axial Screwdriver

5484280 5484111

Multi-Axial Screwdriver Self-Retaining Driver

5484109 5484113
8 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Instrument Set continued

Hook Preparation

Laminar Elevator Pedicle Finder

7480220 7480225

Transverse Process Elevator

7480222

Hook Placement

Hook Pusher for Implant Holder Self-Retaining Implant Holder

5484231 5484217

Lateral Implant Holder Offset Hook Holder

5484211 5484219

Total Anatomical
Straight Implant Holder Hook Instrument
5484216 5484317
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 9

Instrument Set continued

Rod Contouring

Rod Template
5484510

4.75mm Rod Cutter

RC404022-E

French Bender
7480162

Rod Insertion

Rod Pusher*
5484235
*Shown with Adjustable Driver Handle

Rod Rotation Wrench

5484285

Rod Holder
8350312
10 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Instrument Set continued

Rod Reduction

Beale Rod Reducer, Slots Forceps Rocker

5484134 7480142

Beale Rod Reducer, Rocker European Rocker

5484136 7480141

Set Screw Confirmation Tool

Quick Connect Reduction
5484010
Nut Driver
5484011

Inner Sleeve
5484008

Outer Sleeve
5484009

Sequential Reducer
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 11

Instrument Set continued

Correction

Coronal Benders
Left 5484265
Right 5484270

In Situ Benders
Left 5484255
Right 5484260

Dual Action Rod Gripper

5484006
12 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Instrument Set continued

Compression and Distraction

Curved Compressor Multilevel Hook Compressor

5484165 808-503

Small Compressor Distractor Pliers

7480165 5484171

Large Compressor Hinged Translator

7480166 5484172

Parallel Distractor
7480170
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 13

Instrument Set continued

Final Tightening/Set Screws

Dual Ended Twisted Set Screw Starter

5484004
Set Screw Breakoff Driver
8350316

Torque Indicating Driver

5484147

Counter Torque
5484150

Set Screw Obturator

8350322
14 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Instrument Set continued

Additional Instruments

6.35mm Hex Shaft Torx 20 Shaft

Provisional Driver* 815-517
5480131V
*Shown with Adjustable Driver Handle

T27 Obturator Adjustable Driver Handle

7480154 5480140V

Screw Head
Positioner Shaft
5484003

Removal Instruments

Ball-ended T25 Screw

Removal Driver Self-Retaining 3.5mm Hex Driver
5480004V 7480114
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 15

Instrument Set continued

CD HORIZON® X10 CROSSLINK® Plate Implants and Instrument Set

CD HORIZON® X10 CROSSLINK® CD HORIZON® X10 CROSSLINK®

Multi-Span® Plate Fixed Plate

T-bolt Implant Positioners

808-545

Measuring Card
8114506

7/32" Torque-Limiting Set Screwdriver

8110535

Measuring Caliper
8114504

Counter Torque
8110540

In-line Plate Holder

8110511

Plate Benders Bending Irons

8114505

3.0mm Hex Head Shaft, Removal Driver

8110530
16 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Pedicle Screw
Surgical
Technique
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 17

Thoracic Facetectomy and Starting Points

Clean the facet joints and perform After a thorough exposure, use
a partial inferior articular process as much anatomic information
osteotomy to enhance visualization as possible by starting with a
and fusion. Remove 3mm to 5mm neutral, non-rotated vertebra.
of the inferior facet and denude The lateral and posterior views
the articular cartilage on the shown on the following page can
superior facet, except for the lowest be used as a guide for starting
vertebra to be instrumented. This points and screw trajectory.
will allow for the intraoperative
The first and extremely critical step
localization of the thoracic
to performing advanced deformity
pedicle screw starting points.
techniques is the safe and secure
Anatomic starting points vary by placement of segmental pedicle
the posterior elements that can be screws. Knowledge of the Superior
observed intraoperatively. These Facet Rule (A) to direct the medial/
include the transverse process, lateral and the Cephalocaudal
the lateral portion of the pars Starting Points (B) is a helpful
interarticularis, and the base of the reference to accomplish this.
superior articular process.

Superior Facet Rule (A)

Color Reference Chart

Unsafe

Safe

! Important

Cephalocaudal Starting Points (B) Do not start medial to the midpoint

of the superior facet.

Color Reference Chart

T9, T8, T7
T10, T6
T11, T5, T4
T12, T3, T2, T1
18 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Screw Starting Points

Use Fixed Angle or Multi-Axial Screws for the straightforward approach (Blue Pins).
Use Multi-Axial Screws only for the anatomic approach (Green Pins).

Cephalad-Caudad Medial-Lateral T1
T1 Level Starting Point Starting Point
T2
T2 T1 Midpoint Transverse Junction:
Process (TP) TP-Lamina T3
T3
T2 Midpoint TP Junction: T4
T4
TP-Lamina T5
T5
T3 Midpoint TP Junction: T6
T6 TP-Lamina
T4 Junction: Proximal Junction: T7
T7
Third-Midpoint TP TP-Lamina
T8 T8
T5 Proximal Third TP Junction:
T9 TP-Lamina
T9
T10 T6 Junction: Proximal Junction:
Edge-Proximal Third TP TP-Lamina-Facet T10
T11
T7 Proximal TP Midpoint Facet T11
T12
T8 Proximal TP Midpoint Facet T12
L1 T9 Proximal TP Midpoint Facet
L1
L2 T10 Junction: Proximal Junction:
Edge-Proximal Third TP TP-Lamina-Facet L2

T11 Proximal Third TP Just medial to L3

L3
lateral pars
L4
L4 T12 Midpoint TP At the level of
lateral pars L5
L5
S1 L1 Midpoint TP Junction: S1
Lateral pars and
superior facet Iliac
Iliac
L2 Midpoint TP Junction:
Lateral pars and
superior facet
L3 Midpoint TP Junction:
Lateral pars and
superior facet
L4 Midpoint TP Junction:
Lateral pars and
superior facet
L5 Midpoint TP Junction:
Lateral pars and
superior facet
S1 Midpoint Junction:
Sacral Ala Sacral ala and
superior facet
Iliac 1cm Cephalad to 1cm inferior to the
Distal Posterior Superior superior PSIS on the
Iliac Spine (PSIS) medial slope
Axial View Oblique View
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 19

Pedicle Preparation
Create a 3mm-deep posterior Grip the side of the handle to avoid
cortical breach with a high-speed applying too much ventral pressure.
burr. A pedicle blush may be Insert the tip approximately 20mm
visualized suggesting entrance to 25mm (Figure 2), and then
into the cancellous bone at the remove the probe to reorient it so
base of the pedicle. Occasionally, that the tip points medially. Carefully
when preparing small pedicles place the probe into the base of the
located at the apex of the curve, prior hole and use the instrument
the blush will not be evident markings to advance the probe to
due to the limited intrapedicular the desired depth (Figure 3). Rotate
cancellous bone. In this case, use the probe 180° to ensure adequate
the Thoracic Probe to search in the room for the screw.
burred cortical breach for the soft,
funnel-shaped cancellous bone,
which indicates the entrance to the
pedicle. The tip should be pointed
laterally to avoid perforation of
the medial cortex (Figure 1).

Figure 1 Figure 2 Figure 3

20 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Pedicle Preparation continued

Check to ensure that only blood
is coming out of the pedicle and
that the bleeding is not excessive.
Using a flexible ball-tipped
Sounding/Feeler Probe, advance
the instrument to the base (floor)
of the hole to confirm five distinct
bony borders: a floor and four
walls (medial, lateral, superior, and
inferior) (Figure 4). Give special
care to the first 10mm to 15mm
of the tract. Cortically breached Figure 4
pedicles may be salvageable. When
necessary, place bone wax in the
pedicle hole to limit bleeding, then
reposition the probe with a more
appropriate trajectory.
Next, undertap the pedicle by
0.5mm to 1.0mm of the final screw
diameter (Figure 5). Palpate the
tapped pedicle tract with a flexible
Sounding/Feeler Probe. Clamp
a hemostat to the exposed
Sounding/Feeler Probe and
measure the length of the hole
(Figure 6). Select the appropriate
screw diameter and length by both
preoperative measurement and Figure 6
intraoperative observation.

Figure 5
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 21

Enabling Technologies
Triggered intraoperative EMG monitoring, such as the
NIM-ECLIPSE® Spinal System*, may be used to verify the
trajectory within the pedicle. The O-Arm® Intra-operative
Imaging System coupled with the STEALTHSTATION®
Image Guidance System can also be used to navigate
pedicle preparation and screw placement.

Lumbar

Straight

Thoracic

NIM-ECLIPSE® Spinal System* NIM® Pedicle Probes

O-Arm® Imaging System O-Arm® and STEALTHSTATION® System Images

*The NIM-ECLIPSE® Spinal System is manufactured by Axon Systems, Inc. Distributed by Medtronic.
22 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

VERIFYI™ Implant Tracking

The CD HORIZON® SOLERA™ Prior to implantation remove the
Spinal System implants are the tags from the implants (Figure 7).
first to feature the VERIFYI™ When placing fixed or multi-axial
Implant Tracking System, a patent- screws, attach a driver to the screw
pending traceability tool which in the screw caddy to remove the
enables electronic tracking and screw and then break off the tag
documentation of implant part (Figures 8 and 9). Retain all of the
and lot numbers to provide data implant tags so they can be scanned
management benefits for surgeons at the end of the surgery. A tag
and hospitals. Each implant has a holder is available if the surgeon
tag attached that is clearly marked wants to track the implants by spinal
with the part number, lot number, level (Figure 10).
implant size, and a barcode.
Contact your local Medtronic
sales representative for detailed
information on using the VERIFYI™
Implant Tracking System.

! Important Figure 7 Figure 8

The implant tags must be removed prior

to implantation. Do not implant the tags.

Figure 9 Figure 10
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 23

Screw Placement
Thread a screw onto either a fixed
or multi-axial screwdriver. If the
Lock Sleeve Multi-Axial Screw
Driver is used, ensure that the blue
locking cap is not engaged with the
screwdriver shaft, and then thread
the screw onto the driver shaft
(Figure 11). Slide the blue locking
cap toward the screw to engage
it with the driver shaft (Figure 12).
An audible “click” will confirm
engagement.
Slowly advance the screw down the
pedicle to ensure proper tracking
while allowing for viscoelastic
expansion (Figure 13). Once the
screw is inserted, push the button
on the blue locking cap and slide it
back to its original position. Finally,
unthread the Lock Sleeve Multi-Axial
Screw Driver from the screw.
Screws should be placed at every
segment on the correction side
and every third or fourth level on
the stabilizing side. Insert at least
two screws at the proximal and Figure 11 Figure 12
distal ends of the planned construct
on the stabilizing side. For some
pathologies, such as kyphosis and
scoliosis, more screws are placed
for greater construct rigidity. Screws
should be checked radiographically
at this time to ensure intraosseous
screw placement.

Figure 13
24 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Rod Contouring and Placement

Once correct screw placement
has been verified radiographically,
measure and contour rods in the
sagittal and coronal planes.
The titanium alloy rods have an
orientation line that serves as a
reference point during contouring.
Clamping the rod with Dual Action
Rod Grippers at both ends helps
prevent the rod from rotating during
contouring (Figure 14).

Figure 14
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 25

Rod Reduction
For non-hyperkyphotic deformities, Forceps Rocker Method
place the rod on the concavity first.
The contoured rod is placed into the Use of the Forceps Rocker is an the rod and then lever backward
previously placed screws. There are effective method for reducing (or over the rod (Figure 15). The
several methods and instruments seating) the rod into the implant levering action allows the rod to be
that can facilitate fully seating the when only a slight height difference fully seated into the saddle of the
rod into the saddle of the implant. exists between the rod and the implant. The Dual Ended Twisted
implant saddle. To use the Forceps Set Screw Starter is then used to
Rocker, grasp the sides of the introduce the set screw (Figure 16).
! Important implant with the rocker cam above

Care should be taken with any of

the following reduction methods. European Rocker Method
Improper instrument use may loosen
implants or damage the residual The European Rocker can also be instrument backward over the rod
facets and other bony anatomy. used to achieve rod reduction. (Figure 17). The levering action
To use this rocker, grasp the sides allows the rod to be fully seated into
of the implant with the rocker the implant saddle. To remove the
cam above the rod, squeeze the instrument, press the blue button on
handle to secure the instrument the top of the instrument.
to the implant, and then lever the

Figure 15 Figure 16 Figure 17

26 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Rod Reduction continued

Beale Rod Reducer

In situations where the rod rests at Once the Beale Rod Reducer is
the top of the implant, the Beale attached to the implant, squeeze
Rod Reducer may be used to seat the reducer handles slowly, allowing
the rod. There are two types of the sleeve to slide down, and seat
Beale Reducers: the Slot Reducer the rod into the implant saddle. A
attaches to the four implant slots set screw is then placed through the
(Figure 18), and the Rocker Reducer reducer tube and into the implant
attaches to the two holes on the head with the Dual Ended Twisted
sides of the implant (Figure 19), Set Screw Starter. Provisionally
similar to the Forceps Rocker. tighten the set screw with the
Twisted T25 Provisional Driver
(Figure 20).

Figure 18 Figure 19 Figure 20

 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 27

Sequential Reduction
The Sequential Reducer may be
used to gradually seat the rod.
Insert the Inner Sleeve into the
Outer Extender (Figure 21) and
turn the Reduction Nut clockwise
until the word “LOAD” is visible
through the oval window on
the Outer Extender (Figure 22).
Place the Sequential Reducer
on the screw head and turn the
Reduction Nut until the Sequential
Reducer is firmly attached to the
screw head (Figure 23).

Figure 21 Figure 22 Figure 23

28 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Sequential Reduction continued

!
Attach the Quick Connect Reduction After the set screw has been
Important
Nut Driver to the Sequential provisionally tightened, use the Set
Reducer and then attach the Screw Confirmation Tool to verify Do not continue turning the handle once
Quick Connect Ratcheting Handle. that the set screw is fully seated. “LOAD” has passed slightly below the
Turn the handle clockwise until Place the Set Screw Confirmation bottom of the oval window, or the Inner
the rod is fully reduced by visual Tool through the cannulation of the Sleeve will detach from the Outer Sleeve.
confirmation (Figure 24). reducer; if the black line is visible,
the set screw is fully seated.
Attach the set screw to the Dual
Ended Twisted Set Screw Starter and To remove the Sequential Reducer
place it through the cannulation of from the implant, turn the Quick
the reducer (Figure 25). Provisionally Connect Ratcheting Handle
tighten the set screw and then counterclockwise until the word
remove the set screw starter. “LOAD” has passed slightly below
the bottom of the oval window
(Figure 26). An audible "click" may
be heard.

Figure 24 Figure 25 Figure 26

 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 29

Deformity Correction
The set screws are kept loose Tighten the apical set screws cephalad screw above the disc space
(or only locked at one end); and perform the appropriate with the hinged leg proximal to the
then the concave rod is slowly compression or distraction. The straight leg and squeeze the handles
straightened with the left and right Hinged Translator can be used to begin compression (Figure 28). To
Coronal Benders (Figure 27). Each in place of either a compressor use the instrument to distract, place
straightening of the concave rod or a distractor during correction the straight leg against the cephalad
is performed over a pedicle screw. maneuvers. The straight leg of the screw of the disc space and the
Several passes may be required in instrument will push the implant hinged leg proximal to the straight
order for viscoelastic relaxation while the hinged leg engages on the leg and squeeze the handles to
with subsequent curve correction rod to act as rod gripper. To use the begin distraction (Figure 29). Watch
to occur. Hinged Translator as a compressor, the bone-to-screw interface with all
place the straight leg against the correction maneuvers.

Figure 27

Figure 29

Figure 28
30 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Deformity Correction continued

Placing the Stabilizing Rod

Following placement of the second that compression be released tightening step. NMEP and/or SSEP
rod and set screws (Figure 30), just prior to the set screw being monitoring are performed to detect
convex compressive forces are broken off or with final tightening. any potential neurologic deficits.
placed on the segments using the This technique will help ensure Fixation is verified with AP and
Compressor to horizontalize the that the implant head and rod are lateral x-rays to confirm spinal
lowest instrumented vertebra and normalized to one another and thus correction and alignment.
mildly compress the convexity of the allow for the rod to be fully seated
deformity (Figure 31). It is preferred in the implant head during the final

Figure 30 Figure 31
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 31

Final Tightening and Decortication

Using the Counter Torque and the it through the Counter Torque and The posterior elements are
Self-Retaining Breakoff Driver, shear into the inner portion of the set decorticated with a burr and
off the set screws, which locks the screw (Figure 33). Turn the handle the bone graft is placed. The
rods into place (Figure 32). until the needle reaches the line on CD HORIZON® X10 CROSSLINK®
the right side of the scale to ensure Plates should be placed at the
Use the Torque Indicating Driver
the correct torque limit has been proximal and distal ends of the
to verify the correct torque limit
achieved (Figure 34). Continuing to construct. Please refer to the next
has been achieved once the set
tighten the set screw such that the page for detailed instructions on
screws are sheared off. Attach
needle passes this line can result in applying the plates.
the Quick Connect Handle to the
over tightening, which could reduce
Torque Indicating Driver and pass
the effectiveness of the connection.

Figure 34

Figure 32 Figure 33
32 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

CD HORIZON® X10 CROSSLINK® Plate Placement

The surgeon may choose one of several CD HORIZON® X10 CROSSLINK® Plate placement options.

In-line Plate Holder Method

The midline nut is provisionally Screwdriver until it is firmly attached

tightened to gain control of the to the rod (Figure 35). Next, loosen
CD HORIZON® X10 CROSSLINK® the midline nut to appreciate the
MULTI-SPAN® Plate during multiaxial flexibility of the plate and
placement. With the use of the seat the opposite end onto the other
In-line Plate Holder, the plate is rod, followed by final tightening of
selected, gripped, and positioned the break-off set screws to 60 in-lbs
to capture the far rod. Following (6.2-7.3Nm). Finally, tighten the
placement of the plate onto one midline nut to 80 in-lbs, remembering
rod, tighten the set screw using that the midline nut is not a break-off
the 7/32" Torque-Limiting Set set screw (Figure 36).

Figure 35 Figure 36
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 33

CD HORIZON® X10 CROSSLINK® Plate Placement continued

T-Bolt Implant Positioner Method

With the use of the implant set screw can be manipulated and Screwdriver. A Counter Torque may
positioner instruments, the slightly backed out, allowing the rod be placed on the CD HORIZON®
appropriate CD HORIZON® X10 to fully seat in the ventral opening. X10 CROSSLINK® MULTI-SPAN® Plate
CROSSLINK® MULTI-SPAN® Plate is Once precise contact has been to minimize torque transfer to the
selected and gripped (Figure 37). achieved between the plate and the construct during final tightening.
Ensure that both positioners fit rod, the positioners can be used to The screwdriver shaft is introduced
securely onto both set screws. provisionally tighten the plate to the through the Counter Torque. The
rod. The same process is carried out set screws are sheared off using the
The T-bolt Implant Positioners can be
for the other side of the plate. Both screwdriver. The midline nut then
used to sequentially articulate the
halves of the plate should precisely undergoes final tightening with
plate around the rod (Figure 38). If
articulate with the rod before final the same screwdriver. The midline
the plate cannot be precisely seated
tightening and set screw breakoff. nut on the CD HORIZON® X10
against the rod, the set screw is still
CROSSLINK® MULTI-SPAN® Plate is
too prominently extended into the Remove the T-bolt Implant
not a break-off set screw; the driver
ventral opening. Keep the plate in Positioners and provisionally
will “click” when the appropriate
the wound and abutting against the tighten the midline nut using
torque is obtained.
rod. By rotating the positioners, the the 7/32" Torque-Limiting Set

Figure 37 Figure 38
34 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

CD HORIZON® X10 CROSSLINK® Plate Placement continued

Forceps Plate Holder Method

With the use of the Forceps Remove the Forceps Plate Holder the 7/32" Torque-Limiting Set
Plate Holder, the appropriate from both crossbars. Place the Screwdriver. The midline nut then
CD HORIZON® X10 CROSSLINK® Forceps Plate Holder on the crossbar undergoes final tightening with
MULTI-SPAN® Plate is selected and that is able to move (Figure 41). the same screwdriver. The midline
gripped (Figure 39). The forceps Anchor the second side of the plate nut on the CD HORIZON® X10
have a notched tip to securely hold to the rod and provisionally tighten CROSSLINK® MULTI-SPAN® Plate is
both crossbars (Figure 40). the set screw. Remove the Forceps not a break-off set screw; the driver
Plate Holder and provisionally will “click” when the appropriate
Ensure that both crossbars on the
tighten the midline nut. torque is obtained.
CD HORIZON® X10 CROSSLINK®
Plate are gripped. The plate is then A Counter Torque may be placed on
placed to capture the far rod (in the CD HORIZON® X10 CROSSLINK®
relation to the surgeon) of the two MULTI-SPAN® Plate to minimize
rods to be stabilized. Using the 7/32" torque transfer to the construct
Torque-Limiting Set Screwdriver, the during final tightening. The
far rod’s set screw is provisionally screwdriver shaft is introduced
tightened to anchor the device to through the Counter Torque. The
this rod. set screws are sheared off using

Figure 39 Figure 41

Figure 40
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 35

Postoperative Care and Mobilization

Prior to closure do a final check monitoring of neurologic function. methods of getting in and out
to ensure that the set screws are Prophylactic antibiotics may be of bed, stair climbing, and brace
symmetrically seated in the screw continued for a brief duration application, as well as how long
heads and sheared off, that the bone following surgery until the wound to sit and various other activities
graft has not become dislodged seals. Finally, postoperative bracing of daily living. Patients who lag
during manipulation, and that a may be considered for longer behind a normal recovery period
proper count of all sheared-off set fusions depending upon individual proportional to the extent of their
screw heads is correct (Figure 42). surgeon preference. surgery should be expediently
considered for transfer to a
Appropriate postoperative A structured, progressive physical
rehabilitation inpatient facility.
monitoring following evaluation of therapy program is essential to
the extent of the surgical procedure mobilize the patient in order Finally, postoperative follow-up for
and the patient’s overall medical to diminish postoperative a minimum of two years is crucial
status is essential. Deep vein complications and to rehabilitate to assess the progression of fusion
anti-embolic treatment should be the patient sufficiently for discharge. and, equally important, the patient’s
considered for all patients, along During the inpatient rehabilitation clinical improvement.
with active pulmonary toilet, fluid period, patients should be carefully
balance, nutritional status, and instructed in the appropriate

Figure 42
36 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Explantation
The CD HORIZON® SOLERA™ set If removal of a CD HORIZON®
screws (plugs) may be removed X10 CROSSLINK® MULTI-SPAN®
using the T25 Obturator and the Plate is necessary, place the 7/32"
Self-retaining Breakoff Driver. The Torque-Limiting Set Screwdriver
T25 Obturator is inserted into the over the midline nut and turn
working end of the Self-retaining counterclockwise to loosen. Place
Break-off Driver, so that the knurled the 3.0mm Hex Removal Driver into
portion of the T25 Obturator is flush a standard Medtronic Quick Connect
with the driver. Insert the obturator Handle. Place the tip of the 3.0mm
tip through the Counter Torque, internal hex driver into the set screw
which should be seated on the and confirm that the 3.0mm tip is
screw and into the plug, turning completely inserted and seated in
counterclockwise until the plug has the set screw so that the tip does
been removed. The pedicle screws not strip the hex. Turn the driver
may be removed using either the counterclockwise to loosen the set
Multi-Axial Screwdriver or the Self- screw from the rod.
retaining Screwdriver in conjunction
with the Ratcheting Handle. First,
attach the Ratcheting Handle to
the modular end of the driver. Next,
fully engage the T25 end of the
screwdriver into the screw head;
then, if utilizing the Multi-Axial
Screwdriver, thread the instrument
sleeve into the screw head. Turn
counterclockwise until the pedicle
screws have been removed.
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 37

Hook
Surgical
Technique
38 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Surgical Strategy
Preoperatively, any spinal surgery These schemes, which are strictly for treated using a hybrid construct
should be studied and a scheme of illustrative purposes, are examples of consisting of hooks and pedicle
the construct defined. how to treat these types of scoliosis. screws. Figure 44 shows a construct
Figure 43 shows a standard right treating neuromuscular scoliosis
Shown below are examples of
thoracic curve (Lenke Type 1AN/King from T2 to L5.
some typical hook constructs for
Type III) instrumented with hooks
a T4-L1 idiopathic scoliosis and
from T4 to L1. This case can also be
a T2-S1 neuromuscular scoliosis.

taph

ph
h
wbh taP

ph ph
ph
wbh
ph
ph
NBH

ph
ph nbh
NBH
NBH

Hook Construct Legend

nbh
NBH = Narrow Blade Hook

OH = Offset Hook

PH = Pedicle Hook

wbh = Pedicle Screw

pedicle
ebh WBH = Wide Blade Hook screws

= Up-Going Hook

= Down-Going Hook
Figure 43
TAPH = Total Anatomical Pedicle Hook

TATP = Total Anatomical Transverse Process Hook

EBH = Extended Body Hook

Figure 44
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 39

Hook Site Preparation, Options, and Insertion

The CD HORIZON® SOLERA™ Spinal Several different instruments can be
System offers a number of top- used for hook insertion. The Straight
loading hooks of different anatomic or Lateral Implant Holder combined
shapes and sizes (see hook implants with the Hook Pusher (Figure 45).
chart, page 5). Any CD HORIZON®
SOLERA™ Spinal System hook
may be treated as a closed hook
by placing the set screw into the
hook prior to insertion of the
rod. The surgeon must choose
the appropriate hook based on
the individual patient’s anatomy,
deformity degree and type, method
of correction chosen, and amount of
compression/distraction that will be
needed to provide proper and stable
purchase of the implants.

Figure 45
40 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Hook Site Preparation, Options, and Placement

Pedicle Hook

The Pedicle Hook may be used from help of the Pedicle finder
T1 to T10. The hook blade is always (Figure 47), the hook may
cephalad (up-going) and is in the be inserted.
infralaminar position. The facet
If needed, a mallet can be used
capsule is divided, and a portion of
to impact the Pedicle Hook. It is
the inferior facet process may be
important that the Pedicle Hook is
removed to facilitate insertion of the
placed into the joint cavity and is
hook (Figure 46). Once the pedicle
not splitting the inferior articular
has been clearly identified with the
process (Figures 48 and 49).

Figure 46
Figure 47

CORRECT INCORRECT
Figure 48 Figure 49
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 41

Hook Site Preparation, Options, and Placement continued

Transverse Process Hook

This is generally a wide blade hook

and is typically used in a pedicle-
transverse claw construct as a caudal
(down-going) hook (Figure 50).
The Transverse Process Elevator or
the wide blade Laminar Elevator
may be used to separate the
ligamentous attachment between
the undersurface of the transverse
process and the posterior arch of the
rib medial to the rib-transverse joint.
An Implant Holder is used to insert
this hook.

Figure 50
42 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Hook Site Preparation, Options, and Placement continued

Total Anatomical Hooks

TAH™ Total Anatomical Hooks have The TAH Pedicle Hook may be used
a small shelf designed to enhance from T1 to T10. The hook blade is
their stability. The combination of always cephalad (upgoing) and is
the shelf and the close fit of the in the infralaminar position. The
throat of these hooks demands that facet capsule is divided, and a
the angle of insertion is less vertical portion of the inferior facet process
than required by other implants. may be removed to facilitate
To achieve this angle of insertion insertion of the hook (Figure 51).
without violating the cut surface of Once the pedicle has been clearly
the superior articular facet, a small identified with the help of the
amount of the adjacent inferior Pedicle Elevator (Figure 52), the
tranverse process and lamina may hook may be inserted.
need to be removed.

Figure 51 Figure 52
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 43

Hook Site Preparation, Options, and Placement continued

TAH Transverse Process Hook

This hook is typically used in a

transverse process/pedicle claw
construct as a caudal (down-going)
hook (Figure 53). The Transverse
Process Elevator or the Laminar
Elevator may be used to separate
the ligamentous attachment
between the undersurface of the
transverse process and the posterior
arch of the rib medial to the rib/
transverse process joint. An Implant
Holder is used to insert this hook.

Figure 53
44 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Decortication
Once inserted, laminar hooks are At this point in the surgery, bilateral Decortication of the laminae,
not very stable prior to rod insertion. partial facetectomies are carried spinous processes, and transverse
Therefore, it is recommended to out (Figure 54). The intervening processes, along with bone graft
remove them to decorticate. cartilage is denuded to allow placement, will be done at the end
exposure of the subchondral of the surgery to avoid intraoperative
bone assisting in bone fusion. bleeding. Laminar hooks are placed
back into their position.

Figure 54
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 45

Rod Contouring
Once the hooks on the correction contour, the rod is bent in small In a case of stiff scoliosis, the rod
side of the deformity (concave in the incremental steps using a French is placed along the spine to check
thoracic area, convex in the lumbar Bender (Figure 55). It is important to for proper correction, hook fit, and
area of the spine) are tested for fit maintain a same plane orientation contouring. This type of scoliosis
and placement, a rod template may of the rod to prevent a spiral-type correction will be mainly obtained
be used to determine the length bend down the rod. with in situ bending.
and the curve. The correction rod
In the case of a reducible scoliosis,
is cut to the appropriate length
the rod is bent according to the final
(1cm to 2cm longer than the
postoperative planned correction to
overall hook-to-hook length). To
obtain a nice postoperative thoracic
achieve the correct sagittal plane
kyphosis and lumbar lordosis.

Figure 55
46 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Rod Insertion
The contoured rod is placed into in placing the rod. Using the Dual There are several methods and
the top-loading implants beginning Ended Twisted Set Screw Starter, instruments that may be used to
from either the upper or lower set screws are placed into the facilitate rod reduction and to fully
part of the construct, there is no first implants where the rod seats seat the rod into the saddle of the
particular rule for rod insertion. One perfectly. The Rod Pusher may be implants. Refer to the Rod Reduction
can start with the implants in which used to push the rod down in order steps on pages 25 through 28 of
the rod seems to best position and to place a set screw and/or, due to the pedicle screw section of this
facilitate the continuation of the its C-shape, to push the hook into its technique for method options.
insertion (Figures 56 and 57). A correct position (Figure 58).
Rod Holder may be used to assist

Figure 57

Figure 56
Figure 58
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 47

Deformity Correction
At this point of the surgery part of Rod Rotation
the correction has been achieved,
mainly due to translation maneuvers Once the contoured rod and all of tend to back out during rod rotation.
used when inserting the rod. Further the set screws have been placed, Several methods are proposed: use
correction can be accomplished the rod is ready to be rotated of the C-Shaped Rod Pusher, the
with rod rotation and/or in situ into its final position. The rotation placement of C-rings on the rod
bending, depending on the type must be done slowly in order to prior to rotation, placement of the
and stiffness of the curve, and prevent rapid neurologic changes Rod Gripper on the rod just below
completed with compression/ and/or partial pullout or hook the hook to buttress it, or the use
distraction maneuvers. dislodgement. The rotation is done of a hook stabilizer instrument,
using two Dual Action Rod Grippers which is available upon special
(Figure 59). It is important to ordering request.
monitor the interval hooks, which

Figure 59
48 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Deformity Correction continued

Once the rotation of the rod is In Situ Bending
complete and the position of
In Situ Benders may be used for
the hooks is verified, the interval
correction and final adjustment of
hooks’ set screws are provisionally
the rod in the sagittal and/or coronal
tightened to prevent rod derotation.
plane. The rod is bent in small
The hooks should be checked
incremental steps using the two
following all rotation maneuvers and
bender tips positioned near each
the necessary adjustments made
other on the rod (Figure 60).
to ensure that proper placement
is maintained. At this point, the
rod should be fully seated into the
saddle of all of the implants.

Figure 60
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 49

Compression and Distraction

Once the rod is secured in the
implants, distraction and/or
compression are performed to place
the hooks in their final position.
The Multilevel Hook Compressor,
Distractor, Hex Shaft Provisional
Driver, and Rod Gripper are used
to carry out these maneuvers. It
is recommended to use the Rod
Gripper as a stop for distraction
maneuvers rather than the implant
(Figure 61), with the exception of
the inverted claw. Compression
maneuvers are most often
carried out directly on two hooks
(Figure 62). Care should be taken
to ensure that the foot of either
instrument is placed against the Figure 61
implant body and not against
the set screw. It is preferred that
compression be released just prior
to the set screw being broken off
! Important

or final tightened. This technique I t is highly recommended that the set

screw not be broken off or final
will help ensure that the implant
tightened under compression.
head and rod are normalized to one
another, and thus, allows for the
rod to be fully seated in the implant
head during the final tightening
step. After these maneuvers are
complete, the set screw is tightened
with the Hex Shaft Provisional Driver.

Figure 62
50 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Stabilization and Holding Rod Placement

With the completion of the
deformity correction and the
seating of the correction rod, the
opposite side of the construct is
prepared. Measure the length for
the stabilizing rod, then cut. Using
the French Bender, contour the
rod according to the curvature of
the spine and the residual position
of alignment from the correction
rod. Place the contoured rod
into the hooks and provisionally
secure the rod with set screws
(Figure 63). Once the rod is secured
to the implants, distraction and/
or compression are performed
to place the hooks in their final
position. Refer to the previously
described instructions to ensure
the appropriate steps are followed.
It is highly recommended that the Figure 63
set screw not be broken off or final
tightened under compression.
The spine may be decorticated
to carry out the bone fusion and
morselized cancellous bone
placed along the decorticated
spine, extending out over the
transverse processes.
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 51

Final Tightening
When all implants are securely in
place and the rod fully seated, final
tightening and/or break-off of the
set screw heads is performed.
The Counter Torque instrument is
placed over the implant and the rod
(Figure 64). The Set Screw Breakoff
Driver is then placed through the
cannulated Counter Torque. The Self-
Retaining Break-Off Driver provides
adequate leverage for breaking the
set screw heads. The handle of the
Counter Torque device should be
held firmly to prevent torquing of
Figure 64
the construct while the set screw is
secured and sheared off (Figure 65).
The broken-off part of the set
screw is captured in the cannulated
portion of the Self-Retaining Break-
Off Driver. Following final tightening,
the sheared-off portions of the set
screws accumulated in the driver are
removed using the T27 Obturator
shaft (Figure 66).

Figure 66

Figure 65
52 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

CD HORIZON® X10 CROSSLINK® Plate Placement, Closure, and Explantation

Once final tightening of the set screws is completed, it is mandatory that
transverse links be placed to provide rotational stability to the construct.
A framed construct resists rotational forces. Refer to the previously
described instructions for placing CD HORIZON® X10 CROSSLINK® Plates
in the pedicle screw section of this technique. The posterior elements
should be decorticated with a burr followed by bone graft placement
(Figure 67). Wound closure is performed in the customary manner.

Explantation

The CD HORIZON® SOLERA™ set screws (plugs) may be removed using the
T25 Obturator and the Self-retaining Breakoff Driver. The T25 Obturator is
inserted into the working end of the Self-retaining Break-off Driver, so that
that knurled portion of the T25 Obturator is flush with the driver. Insert
the obturator tip through the Counter Torque, which should be seated
on the screw and into the plug, turning clockwise until the plug has been
removed. The hooks may be removed using the Self-Retaining Implant
Holder. Attach the Self-Retaining Implant Holder to the implant and
remove the hook.
If removal of a CD HORIZON® X10 CROSSLINK® MULTI-SPAN® Plate is
necessary, place the 7/32” Torque-Limiting Set Screwdriver over the
midline nut and turn counterclockwise to loosen. Place the 3.0mm Hex
Removal Driver into a standard Medtronic Quick Connect Handle. Place
the tip of the 3.0mm internal hex driver into the set screw and confirm
that the 3.0mm tip is completely inserted and seated in the set screw so
that the tip does not strip the hex. Turn the driver counterclockwise to
loosen the set screw from the rod.

Figure 67
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 53

Product Ordering Information

4.75mm Cobalt Chrome/Titanium Multi-Axial Screws
Catalog Number Description Catalog Number Description
54840004020 4.0mm × 20mm 54840006520 6.5mm × 20mm
54840004030 4.0mm × 30mm 54840006525 6.5mm × 25mm
54840004035 4.0mm × 35mm 54840006530 6.5mm × 30mm
54840004040 4.0mm × 40mm 54840006535 6.5mm × 35mm
54840004045 4.0mm × 45mm 54840006540 6.5mm × 40mm
54840004050 4.0mm × 50mm 54840006545 6.5mm × 45mm
54840004520 4.5mm × 20mm 54840006550 6.5mm × 50mm
54840004525 4.5mm × 25mm 54840006555 6.5mm × 55mm
54840004530 4.5mm × 30mm 54840006560 6.5mm × 60mm
54840004535 4.5mm × 35mm 54840006565 6.5mm × 65mm
54840004540 4.5mm × 40mm 54840007525 7.5mm × 25mm
54840004545 4.5mm × 45mm 54840007530 7.5mm × 30mm
54840004550 4.5mm × 50mm 54840007535 7.5mm × 35mm
54840005020 5.0mm × 20mm 54840007540 7.5mm × 40mm
54840005025 5.0mm × 25mm 54840007545 7.5mm × 45mm
54840005030 5.0mm × 30mm 54840007550 7.5mm × 50mm
54840005035 5.0mm × 35mm 54840007555 7.5mm × 55mm
54840005040 5.0mm × 40mm 54840007560 7.5mm × 60mm
54840005045 5.0mm × 45mm 54840008525 8.5mm × 25mm
54840005050 5.0mm × 50mm 54840008530 8.5mm × 30mm
54840005055 5.0mm × 55mm 54840008535 8.5mm × 35mm
54840005520 5.5mm × 20mm 54840008540 8.5mm × 40mm
54840005525 5.5mm × 25mm 54840008545 8.5mm × 45mm
54840005530 5.5mm × 30mm 54840008550 8.5mm × 50mm
54840005535 5.5mm × 35mm 54840008555 8.5mm × 55mm
54840005540 5.5mm × 40mm 54840008560 8.5mm × 60mm
54840005545 5.5mm × 45mm 54840008565 8.5mm × 65mm
54840005550 5.5mm × 50mm 54840009550 9.5mm × 50mm
54840005555 5.5mm × 55mm 54840009555 9.5mm × 55mm
54840005560 5.5mm × 60mm 54840009560 9.5mm × 60mm
54840006020 6.0mm × 20mm
54840006025 6.0mm × 25mm
54840006030 6.0mm × 30mm
54840006035 6.0mm × 35mm
54840006040 6.0mm × 40mm
54840006045 6.0mm × 45mm
54840006050 6.0mm × 50mm
54840006055 6.0mm × 55mm
54840006060 6.0mm × 60mm

Screw Color-coding Size Reference

4.0mm 4.5mm 5.0mm 5.5mm 6.0mm 6.5mm 7.5mm 8.5mm 9.5mm

54 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Product Ordering Information continued

4.75mm Cobalt Chrome/Titanium Cannulated Multi-Axial Screws
Catalog Number Description Catalog Number Description
54840015535 5.5mm × 35mm 54840016550 6.5mm × 50mm
54840015540 5.5mm × 40mm 54840016555 6.5mm × 55mm
54840015545 5.5mm × 45mm 54840017530 7.5mm × 30mm
54840015550 5.5mm × 50mm 54840017535 7.5mm × 35mm
54840016535 6.5mm × 35mm 54840017540 7.5mm × 40mm
54840016540 6.5mm × 40mm 54840017545 7.5mm × 45mm
54840016545 6.5mm × 45mm

4.75mm Titanium Set Screws

Catalog Number Description
5440020 Break-off Set Screws

4.75mm Titanium Fixed Angle Screws

Catalog Number Description Catalog Number Description
54410004020 4.0mm × 20mm 54410005555 5.5mm × 55mm
54410004025 4.0mm × 25mm 54410005560 5.5mm × 60mm
54410004030 4.0mm × 30mm 54410006025 6.0mm × 25mm
54410004035 4.0mm × 35mm 54410006030 6.0mm × 30mm
54410004040 4.0mm × 40mm 54410006035 6.0mm × 35mm
54410004045 4.0mm × 45mm 54410006040 6.0mm × 40mm
54410004520 4.5mm × 20mm 54410006045 6.0mm × 45mm
54410004525 4.5mm × 25mm 54410006050 6.0mm × 50mm
54410004530 4.5mm × 30mm 54410006055 6.0mm × 55mm
54410004535 4.5mm × 35mm 54410006525 6.5mm × 25mm
54410004540 4.5mm × 40mm 54410006530 6.5mm × 30mm
54410004545 4.5mm × 45mm 54410006535 6.5mm × 35mm
54410004550 4.5mm × 50mm 54410006540 6.5mm × 40mm
54410005020 5.0mm × 20mm 54410006545 6.5mm × 45mm
54410005030 5.0mm × 30mm 54410006550 6.5mm × 50mm
54410005035 5.0mm × 35mm 54410006555 6.5mm × 55mm
54410005040 5.0mm × 40mm 54410006560 6.5mm × 60mm
54410005045 5.0mm × 45mm 54410007530 7.5mm × 30mm
54410005050 5.0mm × 50mm 54410007535 7.5mm × 35mm
54410005055 5.0mm × 55mm 54410007540 7.5mm × 40mm
54410005520 5.5mm × 20mm 54410007545 7.5mm × 45mm
54410005525 5.5mm × 25mm 54410007550 7.5mm × 50mm
54410005530 5.5mm × 30mm 54410007555 7.5mm × 55mm
54410005535 5.5mm × 35mm 54410007560 7.5mm × 60mm
54410005540 5.5mm × 40mm 54410007565 7.5mm × 65mm
54410005550 5.5mm × 50mm

Screw Color-coding Size Reference

4.0mm 4.5mm 5.0mm 5.5mm 6.0mm 6.5mm 7.5mm 8.5mm 9.5mm

 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 55

Product Ordering Information continued

4.75mm Titanium Hooks
Catalog Number Description Catalog Number Description
5441101 Pedicle Hook, Extra Small 5441143 Ramped, Narrow Blade, Medium
5441102 Pedicle Hook, Small 5441172 Extended Body Hook, Small
5441103 Pedicle Hook, Medium 5441173 Extended Body Hook, Medium
5441104 Pedicle Hook, Large 5441174 Extended Body Hook, Large
5441112 Wide Blade Hook, Small 5441196 Right Offset Hook, Small
5441113 Wide Blade Hook, Medium 5441197 Left Offset Hook, Small
5441114 Wide Blade Hook, Large 5441198 Right Offset Hook, Large
5441122 Narrow Blade Hook, Small 5441199 Left Offset Hook, Large
5441123 Narrow Blade Hook, Medium 5441302 Total Anatomical Pedicle Hook, Small
5441124 Narrow Blade Hook, Large 5441303 Total Anatomical Pedicle Hook, Medium
5441133 Ramped, Wide Blade, Medium 5441342 Total Anatomical Transverse Process
Hook, Small
5441142 Ramped, Narrow Blade, Small
5441343 Total Anatomical Transverse Process
Hook, Medium

4.75mm Rods
Catalog Number Description Catalog Number Description
1475001030 30mm Pre-bent Cobalt Chrome 1475001100 100mm Pre-bent Cobalt Chrome
1475001040 40mm Pre-bent Cobalt Chrome 1475001110 110mm Pre-bent Cobalt Chrome
1475001050 50mm Pre-bent Cobalt Chrome 1475001120 120mm Pre-bent Cobalt Chrome
1475001060 60mm Pre-bent Cobalt Chrome 1475000500 500mm Straight Cobalt Chrome
1475001070 70mm Pre-bent Cobalt Chrome 1476000500 500mm Straight Cobalt Chrome Plus
1475001080 80mm Pre-bent Cobalt Chrome 1474000500 500mm Straight Titanium, Lined
1475001090 90mm Pre-bent Cobalt Chrome

4.75mm CD HORIZON® X10 CROSSLINK® Plates, Titanium

Catalog Number Description Catalog Number Description
5442016 16mm Fixed 5442136 36mm-38mm MULTISPAN
5442019 19mm Fixed 5442138 38mm-41mm MULTISPAN
5442022 22mm Fixed 5442141 41mm-45mm MULTISPAN
5442025 25mm Fixed 5442144 44mm-48mm MULTISPAN
5442028 28mm Fixed 5442147 47mm-53mm MULTISPAN
5442031 31mm Fixed 5442152 52mm-64mm MULTISPAN
5442034 34mm Fixed 5442160 60mm-80mm MULTISPAN
5442037 37mm Fixed 8110855 Set Screw

Hook Color-coding Size Reference

Extra Small Small Medium Large

56 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Product Ordering Information continued

Titanium Closed Multi-Axial Iliac Screws*
Catalog Number Description Catalog Number Description
70465540 5.5mm × 40mm 70467560 7.5mm × 60mm
70465550 5.5mm × 50mm 70467570 7.5mm × 70mm
70465560 5.5mm × 60mm 70467580 7.5mm × 80mm
70466550 6.5mm × 50mm 70468570 8.5mm × 70mm
70466560 6.5mm × 60mm 70468580 8.5mm × 80mm
70466570 6.5mm × 70mm 70468590 8.5mm × 90mm

Titanium Iliac Screws*

Catalog Number Description Catalog Number Description
7040650 6.5mm × 50mm, 0° 7041780 7.5mm × 80mm, 10°
7040660 6.5mm × 60mm, 0° 7041870 8.5mm × 70mm, 10°
7040670 6.5mm × 70mm, 0° 7041880 8.5mm × 80mm, 10°
7040760 7.5mm × 60mm, 0° 7041890 8.5mm × 90mm, 10°
7040770 7.5mm × 70mm, 0° 7042650 6.5mm × 50mm, 20°
7040780 7.5mm × 80mm, 0° 7042660 6.5mm × 60mm, 20°
7040870 8.5mm × 70mm, 0° 7042670 6.5mm × 70mm, 20°
7040880 8.5mm × 80mm, 0° 7042760 7.5mm × 60mm, 20°
7040890 8.5mm × 90mm, 0° 7042770 7.5mm × 70mm, 20°
7041650 6.5mm × 50mm, 10° 7042780 7.5mm × 80mm, 20°
7041660 6.5mm × 60mm, 10° 7042870 8.5mm × 70mm, 20°
7041670 6.5mm × 70mm, 10° 7042880 8.5mm × 80mm, 20°
7041760 7.5mm × 60mm, 10° 7042890 8.5mm × 90mm, 20°
7041770 7.5mm × 70mm, 10°

Titanium Iliac Set Screws

Catalog Number Description
7049855 Hex Break-off Set Screws

Titanium Iliac Lateral Connectors (May be ordered as extras.)

Catalog Number Description
5443120 4.75mm/6.35mm Closed, 20mm
5443130 4.75mm/6.35mm Closed, 30mm
5443160 4.75mm/6.35mm Closed, 60mm

*Lateral Connectors must be used with CD HORIZON® System Iliac Screws.

 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 57

Important Product Information

IMPORTANT INFORMATION ON THE CD HORIZON® Spinal System 13. Any patient in which implant utilization would interfere with anatomical structures or expected
PURPOSE physiological performance.
The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal 14. Any patient unwilling to follow postoperative instructions.
segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. 15. Any case not described in the indications.
DESCRIPTION NOTA BENE: Although not absolute contraindications, conditions to be considered as potential
The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, factors for not using this device include:
CROSSLINK® Plates, staples and connecting components, as well as implant components from other 1. Severe bone resorption.
Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each 2. Osteomalacia.
construct being tailor-made for the individual case.
3. Severe osteoporosis.
Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON®
Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, POTENTIAL ADVERSE EVENTS
connectors, staples and washer, GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; All of the possible adverse events associated with spinal fusion surgery without instrumentation are
LIBERTY® rods and screws; DYNALOK® PLUS and DYNALOK CLASSIC® bolts along with rod/bolt possible. With instrumentation, a listing of potential adverse events includes, but is not limited to:
connectors; and Medtronic Multi-Axial rods and screws. Please note that certain components are 1. Early or late loosening of any or all of the components.
specifically designed to connect to Ø3.5mm, Ø4.5mm, Ø5.5mm rods or Ø6.35mm rods, while other
2. Disassembly, bending, and/or breakage of any or all of the components.
components can connect to both Ø5.5mm rods and Ø6.35mm rods. Care should be taken so that the
correct components are used in the spinal construct. 3. Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, and/
or general corrosion), including metallosis, staining, tumor formation, and/or autoimmune disease.
CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON®
ECLIPSE® rods and associated screws are intended for anterior use only. However, for patients of 4. Pressure on the skin from component parts in patients with inadequate tissue coverage over the
smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly. implant possibly causing skin penetration, irritation, fibrosis, neurosis, and/or pain. Bursitis. Tissue
or nerve damage caused by improper positioning and placement of implants or instruments.
The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless
steel, medical grade titanium, titanium alloy, medical grade cobalt-chromium-molybdenum alloy, or 5. Post-operative change in spinal curvature, loss of correction, height, and/or reduction.
medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated 6. Infection.
with hydroxyapatite. No warranties express, or implied, are made. Implied warranties of merchantability 7. Dural tears, pseudomeningocele, fistula, persistent CSF leakage, meningitis.
and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog for further
information about warranties and limitations of liability 8. Loss of neurological function (e.g., sensory and/or motor), including paralysis (complete or
incomplete), dysesthesias, hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy,
Never use stainless steel and titanium implant components in the same construct. and/or the development or continuation of pain, numbness, neuroma, spasms, sensory loss,
Medical grade titanium, titanium alloy and/or medical grade cobalt-chromium-molybdenum alloy tingling sensation, and/or visual deficits.
may be used together. Never use titanium, titanium alloy and/or medical grade cobalt-chromium- 9. Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia,
molybdenum alloy with stainless steel in the same construct. paraparesis, reflex deficits, irritation, arachnoiditis, and/or muscle loss.
The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy 10. Urinary retention or loss of bladder control or other types of urological system compromise.
(Nitinol – NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy and cobalt-chromium-
molybdenum alloy. Do not use with stainless steel. 11. Scar formation possibly causing neurological compromise or compression around nerves
and/or pain.
PEEK OPTIMA-LT1 implants may be used with stainless steel, titanium or cobalt-chromium-
molybdenum alloy implants. 12. Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the
sacrum, pedicles, and/or vertebral body) and/or bone graft or bone graft harvest site at, above, and/
CD HORIZON® PEEK Rods are not to be used with CROSSLINK® Plates. or below the level of surgery. Retropulsed graft.
To achieve best results, do not use any of the CD HORIZON® Spinal System implant components with 13. Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.
components from any other system or manufacturer unless specifically allowed to do so in this or
another Medtronic document. As with all orthopaedic and neurosurgical implants, none of the CD 14. Non-union (or pseudarthrosis). Delayed union. Mal-union.
HORIZON® Spinal System components should ever be reused under any circumstances. 15. Loss of or increase in spinal mobility or function.
INDICATIONS 16. Inability to perform the activities of daily living.
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, 17. Bone loss or decrease in bone density, possibly caused by stresses shielding.
non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease 18. Graft donor site complications including pain, fracture, or wound healing problems.
(defined as back pain of discogenic origin with degeneration of the disc confirmed by history and
19. Ileus, gastritis, bowel obstruction or loss of bowel control or other types of gastrointestinal
radiographic studies) spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures
system compromise.
(i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.
20. Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke, excessive
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal
bleeding, phlebitis, wound necrosis, wound dehiscence, damage to blood vessels, or other types of
System may also be used for the same indications as an adjunct to fusion.
cardiovascular system compromise.
With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD
21. Reproductive system compromise, including sterility, loss of consortium, and sexual dysfunction.
HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned
indications in skeletally mature patients as an adjunct to fusion. 22. Development of respiratory problems, e.g. pulmonary embolism, atelectasis, bronchitis,
pneumonia, etc.
The CD HORIZON SPIRE™ Plate is a posterior, non-pedicle supplemental fixation device intended for
use in the non-cervical spine (T1-S1) as an adjunct to fusion. It is intended for plate fixation/attachment 23. Change in mental status.
to spinous processes for the purpose of achieving supplemental fusion in the following conditions: 24. Death.
degenerative disc disease (as previously defined); spondylolisthesis, trauma; and/or tumor. Note: Additional surgery may be necessary to correct some of these potential adverse events.
In order to achieve additional levels of fixation as an adjunct to fusion, the CD HORIZON® Spinal System WARNING
rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer
to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use. The safety and effectiveness of pedicle screw spinal systems have been established only for spinal
conditions with significant mechanical instability or deformity requiring fusion with instrumentation.
CONTRAINDICATIONS These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral
Contraindications include, but are not limited to: spine secondary to degenerative spondylolisthesis with objective evidence of neurologic impairment,
1. Active infectious process or significant risk of infection (immuno¬compromise). fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The safety and effectiveness of this device for any other conditions are unknown. The implants are
2. Signs of local inflammation.
not prostheses.
3. Fever or leukocytosis.
In the absence of fusion, the instrumentation and/or one or more of its components can be expected to
4. Morbid obesity. pull out, bend or fracture as a result of exposure to every day mechanical stresses.
5. Pregnancy. PRECAUTION
6. Mental illness. The implantation of pedicle screw spinal systems should be performed only by experienced spinal
7. Grossly distorted anatomy caused by congenital abnormalities. surgeons with specific training in the use of this pedicle screw spinal system because this is a
8. Any other medical or surgical condition which would preclude the potential benefit of spinal technically demanding procedure presenting a risk of serious injury to the patient.
implant surgery, such as the presence of congenital abnormalities, elevation of sedimentation rate A successful result is not always achieved in every surgical case. This fact is especially true in spinal
unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the surgery where many extenuating circumstances may compromise the results. This device system is not
WBC differential count. intended to be the sole means of spinal support. Use of this product without a bone graft or in cases
9. Suspected or documented metal allergy or intolerance. that develop into a non-union will not be successful. No spinal implant can withstand body loads without
the support of bone. In this event, bending, loosening, disassembly and/or breakage of the device(s)
10. Any case not needing a bone graft and fusion. will eventually occur.
11. Any case where the implant components selected for use would be too large or too small to achieve Preoperative and operating procedures, including knowledge of surgical techniques, good reduction,
a successful result. and proper selection and placement of the implants are important considerations in the successful
12. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock utilization of the system by the surgeon. Further, the proper selection and compliance of the patient
or quality. will greatly affect the results. Patients who smoke have been shown to have an increased incidence
of non-unions. These patients should be advised of this fact and warned of this consequence. Obese,
58 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Important Product Information continued

malnourished, and/or alcohol abuse patients are also poor candidates for spine fusion. Patients with sure that none loosened during the tightening of the other nuts or screws. Failure to do so may
poor muscle and bone quality and/or nerve paralysis are also poor candidates for spine fusion. cause loosening of the other components.
PHYSICIAN NOTE: Although the physician is the learned intermediary between the company and the POSTOPERATIVE
patient, the important medical information given in this document should be conveyed to the patient. The physician's postoperative directions and warnings to the patient, and the corresponding patient
compliance, are extremely important.
!USA For US Audiences Only
1. Detailed instructions on the use and limitations of the device should be given to the patient. If partial
CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A weight-bearing is recommended or required prior to firm bony union, the patient must be warned
PHYSICIAN. that bending, loosening and/or breakage of the device(s) are complications which may occur as
a result of excessive or early weight-bearing or muscular activity. The risk of bending, loosening,
Other preoperative, intraoperative, and postoperative warnings and precautions are as follows:
or breakage of a temporary internal fixation device during postoperative rehabilitation may be
IMPLANT SELECTION increased if the patient is active, or if the patient is debilitated or demented. The patient should be
The selection of the proper size, shape and design of the implant for each patient is crucial to the warned to avoid falls or sudden jolts in spinal position.
success of the procedure. Metallic surgical implants are subject to repeated stresses in use, and their 2. To allow the maximum chances for a successful surgical result, the patient or devices should not be
strength is limited by the need to adapt the design to the size and shape of human bones. Unless great exposed to mechanical vibrations or shock that may loosen the device construct. The patient should
care is taken in patient selection, proper placement of the implant, and postoperative management to be warned of this possibility and instructed to limit and restrict physical activities, especially lifting
minimize stresses on the implant, such stresses may cause metal fatigue and consequent breakage, and twisting motions and any type of sport participation. The patient should be advised not to smoke
bending or loosening of the device before the healing process is complete, which may result in further tobacco or utilize nicotine products, or to consume alcohol or non-steroidals or anti-inflammatory
injury or the need to remove the device prematurely. medications such as aspirin during the bone graft healing process.
DEVICE FIXATION 3. The patient should be advised of their inability to bend or rotate at the point of spinal fusion and
In cases where a percutaneous posterior approach is used refer to the CD HORIZON® SEXTANT® taught to compensate for this permanent physical restriction in body motion.
surgical technique. 4. Failure to immobilize a delayed or non-union of bone will result in excessive and repeated stresses
MEDTRONIC CD HORIZON® Spinal System instrumentation contains 3.5mm, 4.5 mm, 5.5mm and/or on the implant. By the mechanism of fatigue, these stresses can cause the eventual bending,
6.35mm rods and implants, which are intended to be used with device specific instruments. loosening, or breakage of the device(s). It is important that immobilization of the spinal surgical site
For self breaking plugs, always hold the assembly with the Counter Torque device. Tighten and break-off be maintained until firm bony union is established and confirmed by roentgenographic examination.
the head of the plug to leave the assembly at optimum fixation security. After the upper part of the self If a state of non-union persists or if the components loosen, bend, and/or break, the device(s)
breaking plug has been sheared off, further re-tightening is not necessary and not recommended. The should be revised and/or removed immediately before serious injury occurs. The patient must be
head part should not remain in the patient. AFTER THE UPPER PART OF THE SELF BREAKING PLUG adequately warned of these hazards and closely supervised to insure cooperation until bony union
HAS BEEN SHEARED OFF, RE-ADJUSTMENT IS NOT POSSIBLE UNLESS THE PLUG IS REMOVED AND is confirmed.
REPLACED WITH A NEW ONE. 5. As a precaution, before patients with implants receive any subsequent surgery (such as dental
When using DTT Transverse Links, the M6 plug should be tightened to between 8 and 9 Nm. (70 to procedures), prophylactic antibiotics may be considered, especially for high-risk patients.
80 inch-lbs). 6. The CD HORIZON® Spinal System implants are temporary internal fixation devices. Internal fixation
CD HORIZON® PEEK Rods are not to be used with CROSSLINK® Plates. devices are designed to stabilize the operative site during the normal healing process. After the
spine is fused, these devices serve no functional purpose and may be removed. While the final
PREOPERATIVE decision on implant removal is, of course, up to the surgeon and patient, in most patients, removal
1. Only patients that meet the criteria described in the indications should be selected. is indicated because the implants are not intended to transfer or support forces developed during
2. Patient conditions and/or pre dispositions such as those addressed in the aforementioned normal activities. If the device is not removed following completion of its intended use, one or more
contraindications should be avoided. of the following complications may occur: (1) Corrosion, with localized tissue reaction or pain;
(2) Migration of implant position, possibly resulting in injury; (3) Risk of additional injury from
3. Care should be used in the handling and storage of the implant components. The implants should
postoperative trauma; (4) Bending, loosening and breakage, which could make removal impractical
not be scratched or otherwise damaged. Implants and instruments should be protected during
or difficult; (5) Pain, discomfort, or abnormal sensations due to the presence of the device; (6)
storage, especially from corrosive environments.
Possible increased risk of infection; (7) Bone loss due to stress shielding; and (8) Potential unknown
4. An adequate inventory of implants should be available at the time of surgery, normally a quantity in and/or unexpected long term effects such as carcinogenesis. Implant removal should be followed by
excess of what is expected to be used. adequate postoperative management to avoid fracture, re-fracture, or other complications.
5. Since mechanical parts are involved, the surgeon should be familiar with the various components 7. Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is
before using the equipment and should personally assemble the devices to verify that all parts and not possible. As with all orthopedic implants, the CD HORIZON® Spinal System components should
necessary instruments are present before the surgery begins. The CD HORIZON® Spinal System never be reused under any circumstances.
components (described in the DESCRIPTION section) are not to be combined with the components
PACKAGING
from another manufacturer.
Packages for each of the components should be intact upon receipt. If a loaner or consignment system
6. All components and instruments should be cleaned and sterilized before use. Additional sterile
is used, all sets should be carefully checked for completeness and all components including instruments
components should be available in case of an unexpected need.
should be carefully checked to ensure that there is no damage prior to use. Damaged packages or
INTRAOPERATIVE products should not be used, and should be returned to Medtronic.
1. Extreme caution should be used around the spinal cord and nerve roots. Damage to the nerves will CLEANING AND DECONTAMINATION
cause loss of neurological functions.
Unless just removed from an unopened Medtronic package, all instruments and implants must be
2. Breakage, slippage, or misuse of instruments or implant components may cause injury to the disassembled (if applicable) and cleaned using neutral cleaners before sterilization and introduction
patient or operative personnel. into a sterile surgical field or (if applicable) return of the product to Medtronic. Cleaning and disinfecting
3. The rods should not be repeatedly or excessively bent. The rods should not be reverse bent in the of instruments can be performed with aldehyde-free solvents at higher temperatures. Cleaning and
same location. Use great care to insure that the implant surfaces are not scratched or notched, decontamination must include the use of neutral cleaners followed by a deionized water rinse.
since such actions may reduce the functional strength of the construct. If the rods are cut to length, Note: Certain cleaning solutions such as those containing formalin, glutaraldehyde, bleach and/or other
they should be cut in such a way as to create a flat, non-sharp surface perpendicular to the midline alkaline cleaners may damage some devices, particularly instruments; these solutions should not be
of the rod. Cut the rods outside the operative field. Whenever possible, use pre-cut rods of the used. Also, many instruments require disassembly before cleaning.
length needed.
All products should be treated with care. Improper use or handling may lead to damage and/or possible
4. Utilize an imaging system to facilitate surgery. improper functioning of the device.
5. To insert a screw properly, a guide wire should first be used, followed by a sharp tap. Caution: Be STERILIZATION
careful that the guide-wire, if used, is not inserted too deep, becomes bent, and/or breaks. Ensure
Unless marked sterile and clearly labeled as such in an unopened sterile package provided by the
that the guide-ire does not advance during tapping or screw insertion. Remove the guide-wire and
company, all implants and instruments used in surgery must be sterilized by the hospital prior to use.
make sure it is intact. Failure to do so may cause the guide wire or part of it to advance through the
Remove all packaging materials prior to sterilization. Only sterile products should be placed in the
bone and into a location that may cause damage to underlying structures.
operative field. Unless specified elsewhere, these products are recommended to be steam sterilized by
6. Caution: Do not overtap or use a screw/bolt that is either too long or too large. Overtapping, using the hospital using one of the sets of process parameters below:
an incorrectly sized screw/bolt, or accidentally advancing the guidewire during tap or screw/bolt
insertion, may cause nerve damage, hemorrhage, or the other possible adverse events listed
elsewhere in this package insert. If screws/bolts are being inserted into spinal pedicles, use as large METHOD CYCLE TEMPERATURE EXPOSURE TIME
a screw/bolt diameter as will fit into each pedicle. Steam Pre-Vacuum 270°F (132°C) 4 Minutes
7. Bone graft must be placed in the area to be fused and graft material must extend from the upper to
the lower vertebrae being fused. Steam Gravity 250°F (121°C) 60 Minutes
8. To assure maximum stability, two or more CROSSLINK® plates or DTT Transverse Links on two Steam* Pre-Vacuum* 273°F (134°C)* 20 Minutes*
bilaterally placed, continuous rods, should be used whenever possible.
9. Bone cement should not be used because the safety and effectiveness of bone cement has not Steam* Gravity* 273°F (134°C)* 20 Minutes*
been determined for spinal uses, and this material will make removal of the components difficult
NOTE: Because of the many variables involved in sterilization, each medical facility should calibrate
or impossible. The heat generated from the curing process may also cause neurologic damage and
and verify the sterilization process (e.g. temperatures, times) used for their equipment. *For outside
bone necrosis.
the United States, some non-U.S. Health Care Authorities recommend sterilization according to these
10. Before closing the soft tissues, provisionally tighten (finger tighten) all of the nuts or screws, parameters so as to minimize the potential risk of transmission of Creutzfeldt-Jakob disease, especially
especially screws or nuts that have a break-off feature. Once this is completed go back and firmly of surgical instruments that could come into contact with the central nervous system.
tighten all of the screws and nuts. Recheck the tightness of all nuts or screws after finishing to make
 CD HORIZON® SOLERA™ Spinal System | Surgical Technique 59

Important Product Information continued

PRODUCT COMPLAINTS
Any Health Care Professional (e.g., customer or user of this system of products), who has any
complaints or who has experienced any dissatisfaction in the product quality, identity, durability,
reliability, safety, effectiveness and/or performance, should notify the distributor, Medtronic. Further,
if any of the implanted spinal system component(s) ever “malfunctions,” (i.e., does not meet any of its
performance specifications or otherwise does not perform as intended), or is suspected of doing so,
the distributor should be notified immediately. If any Medtronic product ever “malfunctions” and may
have caused or contributed to the death or serious injury of a patient, the distributor should be notified
immediately by telephone, FAX or written correspondence. When filing a complaint, please provide the
component(s) name and number, lot number(s), your name and address, the nature of the complaint
and notification of whether a written report from the distributor is requested.
FURTHER INFORMATION
Recommended directions for use of this system (surgical operative techniques) are available at no
charge upon request. If further information is needed or required please contact MEDTRONIC.

Medtronic B.V. Medtronic Sofamor Danek USA, Inc.

Earl Bakkenstraat 10 1800 Pyramid Place
6422 PJ Heerlen Memphis, TN 38132
The Netherlands Telephone 800 933 2635 (In U.S.A.)
Tel: + 31 45 566 80 00 901 396 3133 (Outside of U.S.A.)
Fax 901 396 0356

©2009 Medtronic Sofamor Danek USA, Inc. All rights reserved.

Contact customer service or your sales representative for the most up-to-date version of the package
insert and surgical technique.
60 CD HORIZON® SOLERA™ Spinal System | Surgical Technique

Notes
www.medtronic.com

Medtronic The surgical technique shown is

Spinal and Biologics Business for illustrative purposes only. The
Worldwide Headquarters technique(s) actually employed in
each case will always depend upon

©2009 Medtronic Sofamor Danek USA, Inc. All Rights Reserved. IRN10853-1.0-03/0210
2600 Sofamor Danek Drive the medical judgment of the surgeon
Memphis, TN 38132 exercised before and during surgery
as to the best mode of treatment for
1800 Pyramid Place each patient.
Memphis, TN 38132
Please see the package insert for the
(901) 396-3133 complete list of indications, warnings,
(800) 876-3133 precautions, and other important
Customer Service: (800) 933-2635 medical information.

For more information visit

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