5. USAGE
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 spondylolisthesis (grades 3
and 4) of the L5-S1 vertebra, degenerative spondylolisthesis
with objective evidence of neurologic 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
systems should be performed only by experienced spinal
surgeons 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.
The surgeon must be thoroughly knowledgeable not only in
the medical and surgical aspects of the implant, but must
also be aware of the mechanical and metallurgical limitations
of metallic surgical implants. Postoperative care is extremely
important. The patient must be instructed in the limitations
of the metallic implant and be warned regarding weight
bearing and body stresses on the appliance prior to firm
bone healing. The patient should be warned that
noncompliance with postoperative instructions could lead to
failure of the implant and possible need thereafter for
additional surgery to remove the device.
Refer to the individual system surgical technique manuals for
additional important information.
DePuy Spine Spinal System components should not be used
with components from other manufacturers.
Stainless steel components may interfere with the quality of
imaging obtained using MRI.
During the surgical procedure, the rods may be cut to size
and shaped to provide correction and maintain proper
anatomic lordotic and kyphotic alignment.
When using anterior thoracic/lumbar screw fixation systems,
staples, staple washers and washers are available to optimize
proper staple/screw/rod alignment and stability.
Screw diameters of 11mm and 12mm are indicated for use
only in the sacrum or Ilium. Pre-operative use of CT imaging
to determine the appropriate screw diameter, length,
insertion trajectory, and clearance is strongly recommended
when large diameter screws are indicated.
After solid fusion occurs, these devices serve no functional
purpose and may be removed. In some cases, removal is
indicated because the implants are not intended to transfer
or to support forces developed during normal activities. Any
decision to remove the device must be made by the physician
and the patient taking into consideration the patient’s
general medical condition and the potential risk to the
patient of a second surgical procedure.
These devices are not intended or expected to be the only
mechanism for support of the spine. Regardless of the
etiology of the spinal pathology, for which implantation of
these devices was chosen, it is the expectation and
requirement that a spinal fusion or arthrodesis be planned
and obtained. Without solid biological support provided by
spinal fusion, the devices cannot be expected to support the
spine indefinitely and will fail in any of several modes. These
modes may include bone-metal interface failure, implant
fracture, or bone failure.
57
DePuy Synthes Companies
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EXPEDIUM VERSE System
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System Guide
Summary of Contents for EXPEDIUM VERSE
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