Synthes SYNMESH User manual

Surgical Technique
Vertebral Body System for the Cervical, Thoracic and Lumbar Spine
SYNMESH™

Image intensifier control
This description alone does not provide sufficient background for direct use
of DePuy Synthes products. Instruction by a surgeon experienced in handling
these products is highly recommended.
Processing, Reprocessing, Care and Maintenance
For general guidelines, function control and dismantling of multi-part
instruments, as well as processing guidelines for implants, please contact your
local sales representative or refer to:
http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance
For general information about reprocessing, care and maintenance of Synthes
reusable devices, instrument trays and cases, as well as processing of Synthes
non-sterile implants, please consult the Important Information leaflet
(SE_023827) or refer to:
http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

SYNMESH™ Surgical Technique DePuy Synthes 1
AO Spine Principles 2
Indications and Contraindications 3
Round Implants 4
Oblong Implants 7
Locking Screws 10
Surgical Technique 11
Instruments 18
Bibliography 20
Table of Contents

2 DePuy Synthes Surgical Technique SYNMESH™
The four principles to be considered as the foundation for
proper spine patient management underpin the design
and delivery of the Curriculum: Stability – Alignment–
Biology – Function.1,2
Stability
Stabilization to achieve
a specific therapeutic
outcome
Biology
Etiology, pathogenesis,
neural protection,
and tissue healing
Alignment
Balancing the spine in
three dimensions
Function
Preservations and resto-
ration of function to
prevent disability
AO Spine Principles
Copyright © 2012 by AOSpine
1Aebi et al (1998)
2Aebi et al (2007)

SYNMESH™ Surgical Technique DePuy Synthes 3
Indications and Containdications
Please refer to the corresponding Instructions for Use
for specific information on Intended use, Indications,
Contraindications, Warnings and Precautions, Potential
Adverse Events, Undesirable Side Effects and Residual
Risks. Instructions for Use are available at
www.depuysynthes.com/ifu

B 10 mm
4 DePuy Synthes Surgical Technique SYNMESH™
The round implants are designed to treat defects in
the cervical spine.
Round Implants
SYNMESH™, Corpectomy Device, Pure Titanium
Art. No. Bheight
495.341 10 mm 4 mm
495.441 10 mm 5 mm
495.342 10 mm 6 mm
495.442 10 mm 7 mm
495.443 10 mm 8 mm
495.444 10 mm 9 mm
495.343 10 mm 10 mm
495.445 10 mm 11 mm
495.446 10 mm 12 mm
495.601 10 mm 14 mm
495.602 10 mm 16 mm
495.344 10 mm 18 mm
495.603 10 mm 20 mm
495.604 10 mm 22 mm
495.605 10 mm 24 mm
495.447 10 mm 32 mm
04.817.448 10 mm 88 mm

B 12 mm
B 15 mm
SYNMESH™ Surgical Technique DePuy Synthes 5
Art. No. Bheight
495.346 12 mm 4 mm
495.347 12 mm 5 mm
495.348 12 mm 6 mm
495.349 12 mm 7 mm
495.351 12 mm 8 mm
495.352 12 mm 9 mm
495.353 12 mm 10 mm
495.354 12 mm 11 mm
495.355 12 mm 12 mm
495.611 12 mm 14 mm
495.612 12 mm 16 mm
495.451 12 mm 18 mm
495.613 12 mm 20 mm
495.614 12 mm 22 mm
495.615 12 mm 24 mm
495.356 12 mm 32 mm
495.357 12 mm 88 mm
495.361 15 mm 8 mm
495.362 15 mm 10 mm
495.363 15 mm 12 mm
495.364 15 mm 14 mm
495.455 15 mm 16 mm
495.621 15 mm 18 mm
495.622 15 mm 20 mm
495.623 15 mm 22 mm
495.624 15 mm 24 mm
495.365 15 mm 32 mm
495.366 15 mm 88 mm
Round Implants

12 mm 15 mm10 mm
12 mm 15 mm10 mm
6 DePuy Synthes Surgical Technique SYNMESH™
End Rings, round, with locking screw (convex)
Art. No. BAngle
495.411 10 mm 0°
495.414 10 mm 2.5°
495.412 12 mm 0°
495.415 12 mm 2.5°
495.413 15 mm 0°
495.416 15 mm 2.5°
End Rings, round, press fit*
Art. No. BAngle
495.384 10 mm 0°
495.387 10 mm 2.5°
495.385 12 mm 0°
495.388 12 mm 2.5°
495.386 15 mm 0°
495.389 15 mm 2.5°
End Rings, round
• Two fastening mechanisms available: press fit or with
locking screw
• Angles of 0° or 2.5°
• Each end ring increases the overall height of the
implant by 1.5 mm (see step 3 of the Surgical technique)
*No locking screw needed
Round Implants

17 × 22 mm
22 × 28 mm
26 × 33 mm
SYNMESH™ Surgical Technique DePuy Synthes 7
The oblong implants are designed to treat defects in
the thoracic and lumbar spine.
Oblong Implants
SYNMESH, Corpectomy Device, Pure Titanium
Art. No. Dimensions height
495.461 17 × 22 mm 6 mm
495.371 17 × 22 mm 8 mm
495.462 17 × 22 mm 10 mm
495.372 17 × 22 mm 12 mm
495.463 17 × 22 mm 14 mm
495.464 17 × 22 mm 20 mm
495.465 17 × 22 mm 22 mm
495.466 17 × 22 mm 24 mm
495.467 17 × 22 mm 26 mm
495.468 17 × 22 mm 28 mm
495.373 17 × 22 mm 32 mm
495.469 17 × 22 mm 52 mm
495.374 17 × 22 mm 88 mm
495.471 22 × 28 mm 6 mm
495.376 22 × 28 mm 8 mm
495.472 22 × 28 mm 10 mm
495.377 22 × 28 mm 12 mm
495.473 22 × 28 mm 14 mm
495.474 22 × 28 mm 28 mm
495.475 22 × 28 mm 30 mm
495.476 22 × 28 mm 32 mm
495.477 22 × 28 mm 34 mm
495.478 22 × 28 mm 36 mm
495.479 22 × 28 mm 52 mm
495.378 22 × 28 mm 64 mm
495.379 22 × 28 mm 88 mm
495.481 26 × 33 mm 6 mm
495.482 26 × 33 mm 8 mm
495.483 26 × 33 mm 10 mm
495.484 26 × 33 mm 12 mm
495.485 26 × 33 mm 14 mm
495.486 26 × 33 mm 44 mm
495.487 26 × 33 mm 46 mm
495.488 26 × 33 mm 48 mm
495.489 26 × 33 mm 50 mm
495.490 26 × 33 mm 52 mm
495.381 26 × 33 mm 64 mm
495.382 26 × 33 mm 88 mm

17 × 22 mm 22 × 28 mm 26 × 33 mm
17 × 22 mm 22 × 28 mm 26 × 33 mm
8 DePuy Synthes Surgical Technique SYNMESH™
End Rings, oblong, press fit*
Anterolateral end rings
Art. No. Dimensions Angle
495.391 17 × 22 mm 0°
495.393 17 × 22 mm 5°
495.395 22 × 28 mm 0°
495.397 22 × 28 mm 5°
495.399 26 × 33 mm 0°
495.402 26 × 33 mm 5°
End Rings, oblong
• Two fastening mechanisms available: press fit or with
locking screw
• Angles of 0° or 5°
• Different configurations feature slots for anterolateral,
lateral or anterior insertion under distraction
• Each end ring increases the overall height of the
implant by 3.5 mm (see step 3 of the Surgical technique)
Lateral or anterior end rings
Art. No. Dimensions Angle
495.392 17 × 22 mm 0°
495.394 17 × 22 mm 5°
495.396 22 × 28 mm 0°
495.398 22 × 28 mm 5°
495.401 26 × 33 mm 0°
495.403 26 × 33 mm 5°
*No locking screw needed
Oblong Implants

17 × 22 mm 22 × 28 mm 26 × 33 mm
17 × 22 mm
17 × 22 mm
22 × 28 mm
22 × 28 mm
26 × 33 mm
26 × 33 mm
SYNMESH™ Surgical Technique DePuy Synthes 9
Oblong Implants
Standard Rings
The standard rings fit inside the oblong mesh and are
secured using two M3 locking screws (495.491). They
are designed to provide added stability, particularly for
long implants.
Standard Rings
Art. No. Dimensions
495.405 17 × 22 mm
495.406 22 × 28 mm
495.407 26 × 33 mm
Lateral or anterior end rings
Art. No. Dimensions Angle
495.422 17 × 22 mm 0°
495.424 17 × 22 mm 5°
495.428 22 × 28 mm 0°
495.430 22 × 28 mm 5°
495.434 26 × 33 mm 0°
495.436 26 × 33 mm 5°
End Rings, oblong, with locking screw (convex)
Anterolateral end rings
Art. No. Dimensions Angle
495.421 17 × 22 mm 0°
495.423 17 × 22 mm 5°
495.427 22 × 28 mm 0°
495.429 22 × 28 mm 5°
495.433 26 × 33 mm 0°
495.435 26 × 33 mm 5°

M2
M3
M3
10 DePuy Synthes Surgical Technique SYNMESH™
End rings with locking screw are fixed with one
screw only.
For round end rings with locking screw:
• Locking Screw M2, low profile (495.410),
for B10 mm und 12 mm end rings
• Locking Screw M3, low profile (495.491),
for B15 mm end rings
Matching screwdrivers:
• Screwdriver Shaft 2.0, cruciform, with Holding Sleeve
and Mini Quick Coupling (314.672) and Handle,
small, with Mini Quick Coupling (311.011) for locking
screws M2
• Screwdriver, hexagonal (314.250) for locking screws M3
For oblong end rings with locking screw and for
standard rings:
• Locking Screw M3, low profile (495.491)
Matching screwdriver:
• Screwdriver, hexagonal (314.250) for locking screws M3
Locking Screws

SYNMESH™ Surgical Technique DePuy Synthes 11
Surgical Technique
1. Select approach
SYNMESH can be inserted anteriorly, laterally or antero-
laterally, depending on the spinal level involved.
2. Perform corpectomy and prepare
endplates
Perform a partial or complete corpectomy depending
on the patient’s pathology. Remove the superficial layers
of the cartilaginous endplates until bleeding bone is
exposed.
Warning: Excessive removal of subchondral bone
may weaken the vertebral endplates. If the entire
endplate is removed, subsidence into the adjacent
vertebrae and a loss of segmental stability may result.

60 50 40 10
60 50 40 10
Mesh
Height
3.5 mm
3.5 mm
Oblong
Mesh
Height
1.5 mm
1.5 mm
Round
Construct height
12 DePuy Synthes Surgical Technique SYNMESH™
3. Determine implant size
Distract the affected segment using the parallel Spreader
Forceps (389.187 or 389.188).
The scale on the handle indicates the height of the
defect.
Alternatively, the Calliper for Corpectomy (389.186)
can be used to determine the height of the defect.
When determining the implant size:
• Add a total of 3 mm to the mesh height if using
round end rings
• Add a total of 7 mm to the mesh height if using
oblong end rings
Surgical Technique

SYNMESH™ Surgical Technique DePuy Synthes 13
4. Cut mesh (optional)
If necessary, use the SYNMESH Cutter (397.091) to trim
the mesh to the appropriate height.
a. Mesh, round, B10 mm and 12 mm
Make diagonal cuts.
b. Mesh, round, B15 mm and all oblong meshes
Make diagonal or horizontal cuts.
To determine if the tabs of the mesh need to be adjust-
ed with the Universal Bending Pliers (391.963) line up
the desired end rings with the mesh and adjust tabs as
necessary.
Note: If an end ring with locking screw is used, the
mesh has to be cut on the horizontal.
Surgical Technique

14 DePuy Synthes Surgical Technique SYNMESH™
The following section describes the securing technique
for end rings with locking screw. Alternatively, press fit
end rings may be used.
a. SYNMESH, round, B10 mm and 12 mm
Secure end ring with a locking screw M2 (495.410)
using the Screwdriver Shaft 2.0, cruciform with Holding
Sleeve and Mini Quick Coupling (314.672) and Handle,
small, with Mini Quick Coupling (311.011).
b. SYNMESH, round, B15 mm and all oblong
SYNMESH implants
Secure end ring with a locking screw M3 (495.491)
using the Screwdriver, hexagonal, small, B 2.5mm,
with Groove (314.250).
Note: Check to ensure that end rings are correctly
secured. The locking screw can only be inserted
correctly through one hole. If the screw is inserted
in the wrong hole, a gap will remain between the
end ring and the mesh. In this case, remove the
screw and secure it in the correct hole.
Option:
Fill SYNMESH with bone graft or a bone substitute
material such as chronOS.
5. Attach first end ring
Attach desired end ring to mesh.
Surgical Technique

SYNMESH™ Surgical Technique DePuy Synthes 15
6. Attach second end ring
Attach second end ring as described in the previous step.
Note: If using a longer construct, a standard ring
may be inserted for added stability. Place the stan-
dard ring inside the mesh at the desired location.
Using the hexagonal screwdriver, insert two locking
screws M3 through the mesh and into the standard
ring to secure it in place.
Note: Pack additional bone graft or bone substitute
inside the end rings as needed.
Surgical Technique

3
2
1
16 DePuy Synthes Surgical Technique SYNMESH™
7. Distract and insert implant
Using the parallel spreader forceps, distract the affected
segment until the desired spinal alignment is achieved (1).
While under distraction, insert the SYNMESH implant
using the appropriate implant holder (396.388, 396.389)
(2).
Note: When using oblong end rings, ensure that the
blades of the spreader forceps align with the slots in
the end rings (3). When using round meshes the
spreader forceps must be removed before implanta-
tion.
Final seating of the implant may be accomplished by
gently tapping the implant holder. Once the implant is in
place, carefully remove the implant holder and spreader
forceps. Appropriate impactors may be used if necessary
to achieve final seating of the implant.
Verify the position of SYNMESH in relation to the
vertebral bodies in the frontal and sagittal planes
intraoperatively using an image intensifier.
Surgical Technique

SYNMESH™ Surgical Technique DePuy Synthes 17
8. Apply bone material
The area around SYNMESH close to the vascularised
tissue is the area most likely to fuse and provide stability
later on. Therefore fill this area with the largest possible
amount of bone graft, especially the anterior part of the
instrumented zone.
9. Apply supplemental fixation
As with all vertebral body replacement devices,
SYNMESH must be combined with a supplemental
internal fixation system – e.g. CSLP or USS II – which is
designed for absorbing tensile forces as well as torsional,
exion and extension moments.
Implant Removal
SYNMESH implants are not intended to be removed. If
removal is required, spreader forceps and implant holder
may be used to remove SYNMESH implant.
Surgical Technique

18 DePuy Synthes Surgical Technique SYNMESH™
Instruments
311.011 Handle, small, with Mini Quick Coupling
314.250 Screwdriver, hexagonal, small,
B2.5 mm, with Groove, length 250 mm
314.672 Screwdriver Shaft 2.0, cruciform,
with Holding Sleeve, length 66 mm,
with Mini Quick Coupling
389.186 Calliper for Corpectomy, Stainless Steel
389.187 Spreader Forceps, parallel, distraction
width 0 to 70 mm, Stainless Steel
389.188 Spreader Forceps, parallel, distraction
width 30 to 95 mm, Stainless Steel
391.963 Universal Bending Pliers, length 165 mm