REVISION CONNECTOR
SURGICAL TECHNIQUE
CD Horizon™ ModuLeX
Spinal System
™
REVISION CONNECTOR
SURGICAL TECHNIQUE
CD Horizon™ ModuLeX
Spinal System
™
2 Instruments
3 Connector Selection
4 Connector Attachment
5 Rod Replacement
8 Final Construct
9 Product Order Information
10 Important Product Information
1
INSTRUMENTS
Connector Inserter
5598003
Swizzle Stick
5598041
Rod Gauge
5598005
Set Screw Break-O Driver
5598039
T25 Removal Driver
815-518
Quick Connect
Ratcheting T-Handle
7579000
Connector Counter-Torque
5598044
2
CONNECTOR
SELECTION
To properly place the adjacent screw(s), follow the steps outlined
in the ModuLeX 5.5 surgical technique.
CONNECTOR
SELECTION
Using the rod gauge from the revision instrument set, determine
the rod diameter in the existing construct by placing the rod
gauge around the rod (Figure 1).
First, attempt to attach the 4.75mm connector gauge (magenta
end), if it ts, use the 4.75mm connector (magenta connector).
If the 4.75mm connector gauge does not t, attempt to attach
the 5.5 - 6.0mm connector gauge (blue end), if it ts, use the 5.5
- 6.0mm connector.
Ensure the rod connector fully covers the rod. Use window to
verify placement (Figures 2a and 2b). If the connector gauge does
not fully seat on the rod, the surgeons preferred method of bone
removal should be used to clear bony on-growth from the rod.
Figure 1
Figure 2a Figure 2b
3
CONNECTOR
ATTACHMENT
Once the selected implant is removed from the package, use
the swizzle stick to remove the top loading set screw from the
connector and carefully set aside. Next, attach the swizzle stick
to the side loading set screw and unthread it until the set screw
can no longer be seen in the jaw feature.
Attach the appropriate connector to the connector inserter
(Figure 3). To do this, align the tip of the connector inserter with
the slots on the sides of the connector and squeeze the scissor
grip handle to retain the implant.
Seat the connector around the rod (Figure 4).
Figure 3
Attach the swizzle stick instrument to the side loading set screw
and tighten the revision connector to the existing rod (Figure 5).
Once the set screw is tightened, detach the connector inserter
from the implant.
Figure 4
Figure 5
4
ROD
PLACEMENT
Next, determine the rod length needed, using a rod template.
Place the selected rod (5.5mm diameter) into the head of the
revision connector and align with the new adjacent screw head
(Figure 6). Attach set screws to the swizzle stick and thread them
into the top loading side of the revision connector (Figure 7) and
the new adjacent screw head (Figure 8).
Helpful Hint
The swizzle stick has self-retaining tips to hold the set screws
securely in place. Set screws can be attached to both ends of
the swizzle stick for faster delivery.
To help with rod placement and alignment between the
connector and adjacent head, the swizzle stick can be
connected to the side loading set screw and unthreaded until
the connector can rotate about the existing rod. Once all
implants are properly aligned, the swizzle stick can be used to
provisionally tighten all set screws.
The top loading set screw for the revision connector is
interchangeable with the sterile packed set screw for the
ModuLeX 5.5 screw heads.
Figure 6
Figure 7 Figure 8
5
FINAL
LOCKING
For nal locking of implants, insert the break o driver through
the central hole in the connector counter-torque instrument
(Figure 9a), dock the tip of the break o driver into the set screw
and slide the counter-torque down. To ensure proper alignment
of counter-torque with the implant, verify that the rod is sitting
in the “U” shaped cutout on the counter-torque. If the countertorque is sitting proud, adjust so that the rod can be visually
veried as sitting in the rod slot. While holding the counter
torque handle in place, turn the handle clockwise to break o the
set screw.
Remove the break o driver from the central hole and insert it
into the side hole (Figure 9b). Using the windows in the counter-
torque, connect the tip of the driver to the side load set screw.
While holding the counter torque handle in place, turn the handle
clockwise to break o the set screw.
Figure 9a Figure 9b
6
FINAL
LOCKING
CONTINUE
To break o the set screw connected to the new adjacent screw
head, insert the break o driver through the central hole in the
connector counter-torque instrument or closed counter-torque
instrument (Figure 10), dock the tip of the break o driver into
the set screw and slide the countertorque down. To ensure
proper alignment of countertorque with the implant, verify
that the rod is sitting in the “U” shaped cut-out on the counter
torque. If the counter torque is sitting proud, adjust so that the
rod can be visually veried as sitting in the rod slot. While holding
the counter torque handle in place, turn the handle clockwise to
break o the set screw.
Helpful Hint
The closed counter-torque instrument is available in the
ModuLeX
™
5.5 General Instrument Set.
Figure 10
7
FINAL
CONSTRUCT
Figure 11
8
PRODUCT ORDERING
INFORMATION
Revision Connector Instrument Set (SPS03160)
CFN Description Qty/Set
5598003 Connector Inserter 1
5598005 Rod Gauge 1
5598041 Swizzle Stick 1
5598039 Set Screw Break-O Driver 1
815-518 T25 Removal Driver 1
7579000 Quick Connect Ratcheting T-Handle 1
5598044 Connector Counter-Torque 1
Sterile Suitcase (SPS03155)
CFN Description Qty
559200006 Single Set Screw and single head 4
559200007 Two set screws and two heads 12
559200008 Four Pack Set Screw and four heads 10
G559300145 Sterile Connector 4.5/5.0 2
G559300156 Sterile Connector 5.5/6.0 2
2762-010003
G5598019 Lasso 6
5598916 Suitcase 1
Light Source 3
9
IMPORTANT PRODUCT INFORMATION
ON THE CD HORIZON™ SPINAL SYSTEM
PURPOSE
The CD Horizon
™
Spinal System is intended to help provide immobilization and stabilization
of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.
DESCRIPTION
The CD Horizon
screws, Crosslink
™
Spinal System consists of a variety of shapes and sizes of rods, hooks,
™
Plates, staples, and connecting components, as well as implant
components from other Medtronic spinal systems which can be rigidly locked into a variety of
congurations, with each construct being tailor-made for the individual case.
A subset of CD Horizon
screw xation in pediatric cases. These constructs may be comprised of a variety of shapes
and sizes of rods (ranging in diameter from 3.5 to 6.35mm), hooks, screws, Crosslink
and connecting components. Similar to the CD Horizon
™
Spinal System components may be used for posterior pedicle
™
implants used in adult cases, these
™
plates
components can be rigidly locked into a variety of congurations, with each construct being
tailor-made for the individual case.
Certain components within the CD Horizon
use in pediatric patients. These include PEEK rods, Shape Memory Alloy Staples, Spire
plates, and Dynalok
™
bolts. Screws used in pediatric cases are only cleared for use via a
™
Spinal System are specically excluded for
™
posterior approach. Components used in pediatric cases are fabricated from medical grade
stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromiummolybdenum alloy.
Certain implant components from other Medtronic spinal systems can be used with the
™
Spinal System in non- pediatric cases. These components include TSRH™ rods, hooks,
Con
screws, plates, Crosslink
connectors and Crosslink
and Dynalok Classic
™
plates, connectors, staples and washers, GDLH™ rods, hooks,
™
bar and connectors; Liberty™ rods and screws; Dynalok™ Plus
™
bolts along with rod/bolt connectors; and Medtronic multi-axial rods
and screws. Note: certain components are specically designed to connect to specic rod
diameters, while other components can connect to multiple rod diameters. Care should be
taken so the correct components are used in the spinal construct.
CD Horizon
Horizon
patients of smaller stature and pediatric patients, CD Horizon
components may be used posteriorly.
CD Horizon
steel, medical grade titanium, titanium alloy, medical grade cobalt-chromium-molybdenum
alloy, or medical grade PEEK Optima-LT1. Certain CD Horizon
may be coated with hydroxyapatite. No warranties, expressed or implied, are made. Implied
™
hooks are intended for posterior use only. CD Horizon™ staples and CD
™
Eclipse™ rods and associated screws are intended for anterior use only. However, for
™
Spinal System implant components are fabricated from medical grade stainless
™
4.5mm rods and associated
™
Spinal System components
warranties of merchantability and tness for a particular purpose or use are specically
excluded.
Never use stainless steel and titanium implant components in the same construct.
Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum
alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobaltchromium-molybdenum alloy with stainless steel in the same construct. The CD Horizon
Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol – NiTi).
™
Shape Memory
Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Do
not use with stainless steel. These staples are not to be used in pediatric patients.
PEEK Optima-LT1 implants may be used with titanium or cobalt-chromium-molybdenum
alloy implants. CD Horizon
only to be used with the associated pedicle screws as well as interbody fusion devices in the
anterior spinal column.
To achieve best results, do not use CD Horizon
with components from any other system or manufacturer unless specically allowed to
do so in this or another Medtronic document. As with all orthopaedic and neurosurgical
implants, none of the CD Horizon
any circumstances.
INDICATIONS
The CD Horizon
for posterior, non-cervical xation as an adjunct to fusion for the following indications:
™
PEEK rods are not to be used in pediatric patients. PEEK rods are
™
Spinal System implant components
™
Spinal System components should ever be reused under
™
Spinal System with or without Sextant™ instrumentation is intended
degenerative disc disease (DDD - dened as back pain of discogenic origin with degeneration
of the disc conrmed by history and radiographic studies), spondylolisthesis, trauma (i.e.
fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), tumor,
pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon
Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the
same indications as an adjunct to fusion.
With the exception of DDD, CD Horizon
may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm
™
Legacy™ 3.5mm rods and associated components
™
rods may be used for the specic pediatric indications noted.
When used for posterior non-cervical pedicle screw xation in pediatric patients,
CD Horizon
indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis,
kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital
scoliosis. Additionally, the CD Horizon
diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused
™
Spinal System titanium, cobalt chrome, and stainless steel implants are
™
Spinal System is intended to treat pediatric patients
by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are
to be used with autograft and/or allograft. Pediatric pedicle screw xation is limited to a
posterior approach.
™
The CD Horizon
used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients
PEEK rods are intended to provide posterior supplemental xation when
may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This
device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature
patients. Devices are intended for use with an interbody fusion cage at the instrumented level
and is not intended for stand-alone use.
The CD Horizon
xation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in
™
Spire™ plate is a posterior, single-level, non-pedicle supplemental
skeletally mature patients. It is intended for plate xation/attachment to spinous processes
for the purpose of achieving supplemental xation in the following conditions: DDD,
spondylolisthesis, trauma, and/or tumor.
To achieve additional levels of xation, CD Horizon
to the Vertex
™
Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™
Reconstruction System package insert for a list of Vertex
™
Spinal System rods may be connected
™
indications.
CONTRAINDICATIONS
Contraindications include:
§ Active infectious process or signicant risk of infection (immunocompromise).
§ Signs of local inammation.
§ Fever or leukocytosis.
§ Morbid obesity.
§ Pregnancy.
§ Mental illness.
§ Grossly distorted anatomy caused by congenital abnormalities.
§ Medical or surgical conditions which would preclude the potential benet of spinal implant
surgery such as the presence of congenital abnormalities, elevation of sedimentation rate
unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift
in the WBC dierential count.
§ Suspected or documented metal allergy or intolerance.
§ Cases not needing a bone graft and fusion.
§ Cases where implant components selected for use would be too large or too small to
achieve a successful result.
§ Patients having inadequate tissue coverage over the operative site or inadequate bone
stock or quality.
§ Patients in which implant use would interfere with anatomical structures or expected
physiological performance.
§ CD Horizon
for use in pediatric patients.
™
Spire™ plate and the CD Horizon™ PEEK rods are specically contraindicated
§ Patients unwilling to follow postoperative instructions.
§ Cases not described in the indications.
Nota bene: although not absolute contraindications, conditions to be considered as potential
factors for not using this device include:
§ Severe bone resorption.
§ Osteomalacia.
§ Severe osteoporosis.
POTENTIAL ADVERSE EVENTS
All adverse events associated with spinal fusion surgery without instrumentation are possible.
With instrumentation, a listing of potential adverse events includes:
§ Early or late loosening of components.
§ Disassembly, bending, or breakage of components.
§ Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice,
fretting, or general corrosion) including metallosis, staining, tumor formation, or
autoimmune disease.
§ Pressure on skin from component parts in patients with inadequate tissue coverage over
the implant possibly causing
§ skin penetration, irritation, brosis, necrosis, or pain.
§ Bursitis.
§ Tissue or nerve damage caused by improper positioning and placement of implants or
instruments.
§ Post-operative change in spinal curvature, loss of correction, height, or reduction.
§ Infection.
§ Dural tears, pseudomeningocele, stula, persistent CSF leakage, meningitis.
§ Loss of neurological function (e.g. sensory or motor) including paralysis (complete or
incomplete), dysesthesias, hyperesthesia, anesthesia, paresthesia, appearance of
radiculopathy, or development or continuation of pain, numbness, neuroma, spasms,
sensory loss, tingling sensation, or visual decits.
§ Cauda equina syndrome, neuropathy, neurological decits (transient or permanent),
paraplegia, paraparesis, reex decits,
§ irritation, arachnoiditis, muscle loss.
§ Urinary retention, loss of bladder control, or other types of urological system compromise.
§ Scar formation possibly causing neurological compromise or compression around nerves
or pain.
10
CD HORIZON™ MODULEX™ SPINAL SYSTEM | REVISION CONNECTOR SURGICAL TECHNIQUE
IMPORTANT PRODUCT INFORMATION
§ Fracture, microfracture, resorption, damage, or penetration of spinal bone (including the
sacrum, pedicles, or vertebral body) or bone graft or bone graft harvest site at, above, or
below the level of surgery.
§ Retropulsed graft.
§ Herniated nucleus pulposus, disc disruption, or degeneration at, above, or below the level
of surgery.
§ Non-union (or pseudarthrosis), delayed union, or mal-union.
§ Cessation of any potential growth of the operated portion of the spine.
§ Loss of or increase in spinal mobility or function.
§ Inability to perform activities of daily living.
§ Bone loss or decrease in bone density, possibly caused by stresses shielding.
§ Graft donor site complications including pain, fracture, or wound healing problems.
§ Ileus, gastritis, bowel obstruction, loss of bowel control, or other types of gastrointestinal
system compromise.
§ Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke,
excessive bleeding, phlebitis, wound necrosis, wound dehiscence, damage to blood
vessels, or other types of cardiovascular system compromise.
§ Reproductive system compromise including sterility, loss of consortium, and sexual
dysfunction.
§ Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis,
pneumonia, etc.)
§ Change in mental status.
§ Death.
Note: additional surgery may be necessary to correct some of these potential adverse
events.
ADDITIONAL POTENTIAL ADVERSE EVENTS FOR PEDIATRIC PATIENTS
§ Inability to use pedicle screw xation due to anatomic limitations (pedicle dimensions and/
or distorted anatomy).
§ Pedicle screw malpositioning, with or without neurological or vascular injury.
§ Proximal or distal junctional kyphosis.
§ Pancreatitis.
11
Medtronic
Spinal and Biologics Business
Worldwide Headquarters
2600 Sofamor Danek Drive
Memphis, TN 38132
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
(901) 396-3133
(800) 876-3133
Customer Service: (800) 933-2635
medtronic.com
Please see the package insert for the
complete list of indications, warnings,
precautions, and other important
medical information.
Consult instructions for use at this
website www.medtronic.com/manuals.
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