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The SUMMIT SI OCT System and MOUNTAINEER OCT
Spinal System can also be linked to the ISOLA, MONARCH,
MOSS MIAMI, VIPER and EXPEDIUM systems using the
dual wedding band and axial connectors, and via dual
diameter rods.
WARNING: This device is not approved for screw attach-
ment or fixation to the posterior elements (pedicles) of the
cervical, thoracic (T4-T12), or lumbar spine.
POSTOPERATIVE MOBILIZATION
Until maturation of the fusion is confirmed by radiographic
examination, external immobilization (such as bracing) may
be recommended, based on physician judgment.
Instructions to the patient to reduce stress on the implants
are an equally important part of the attempt to avoid the
occurrence of clinical problems that may accompany
fixation failure.
CONTRAINDICATIONS
•
Active systemic infection or an infection localized to the
site of the proposed implantation.
•
Severe osteoporosis may prevent adequate fixation of
screws and thus preclude the use of this or any other
spinal instrumentation system.
•
Patients who have been shown to be safely and
predictably treated without internal fixation.
•
Open wounds.
RELATIVE CONTRAINDICATIONS
Relative contraindications include any entity or condition
that totally precludes the possibility of fusion (e.g., cancer,
kidney dialysis or osteopenia), obesity, certain degenerative
diseases, and foreign body sensitivity.
Warning: 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. These conditions are
significant mechanical instability or deformity of the thoracic,
lumbar, and sacral spine secondary to severe spondylolis-
thesis (grades 3 and 4) of the L5-S1 vertebra, degenerative
spondylolisthesis with objective evidence of neurological
impairment, fracture, dislocation, scoliosis, kyphosis, spinal
tumor, and failed previous fusion (pseudarthrosis). The
safety and effectiveness of these devices for any other
conditions are unknown.
Precaution: The implantation of pedicle screw spinal sys-
tems should be performed only by experienced spinal sur-
geons with specific training in the use of this pedicle screw
spinal system because this is a technically demanding
procedure presenting a risk of serious injury to the patient.
WARNINGS, PRECAUTIONS AND
ADVERSE EFFECTS CONCERNING
TEMPORARY METALLIC INTERNAL
FIXATION DEVICES.
WARNINGS
The following are specific warnings, precautions and
adverse effects that should be understood by the surgeon and
explained to the patient. These warnings do not include all
adverse effects that can occur with surgery in general, but
are important considerations particular to metallic internal
fixation devices. General surgical risks should be explained
to the patient before surgery.
Potential risks identified with the use of this device system,
which may require additional surgery, include: device com-
ponent fracture, loss of fixation, non-union, fracture of the
vertebra, neurological injury, and vascular or visceral injury.
In addition, please refer to the Surgical Technique Manual
regarding details of safe placement of the occipital screws.
1.
CORRECT SELECTION OF THE IMPLANT IS
EXTREMELY IMPORTANT. The potential for satisfactory
fixation is increased by the selection of the proper size,
shape, and design of the implant. While proper selection
can help minimize risks, the size and shape of human
bones present limitations on the size, shape and strength
of implants. Metallic internal fixation devices cannot
withstand activity levels equal to those placed on normal
healthy bone. No implant can be expected to withstand
indefinitely the unsupported stress of full weight bearing.
2.
IMPLANTS CAN BREAK WHEN SUBJECTED TO THE
INCREASED LOADING ASSOCIATED WITH DELAYED
UNION OR NONUNION. Internal fixation appliances are
load sharing devices that are used to obtain alignment
until normal healing occurs. If healing is delayed, or does
not occur, the implant may eventually break due to metal
fatigue. The degree or success of union, loads produced
by weight bearing, and activity levels will, among other
conditions, dictate the longevity of the implant. Notches,
scratches or bending of the implant during the course
of surgery may also contribute to early failure. Patients
should be fully informed of the risks of implant failure.
3.
MIXING METALS CAN CAUSE CORROSION. There are
many forms of corrosion damage and several of these
occur on metals surgically implanted in humans. General
or uniform corrosion is present on all implanted metals
and alloys. The rate of corrosive attack on metal implant
devices is usually very low due to the presence of pas-
sive surface films. Dissimilar metals in contact, such as
titanium and stainless steel, accelerate the corrosion pro-
cess of stainless steel and more rapid attack occurs. The
presence of corrosion often accelerates fatigue fracture
