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2. Because of the limitations imposed by anatomic considerations
and modern surgical materials, metallic implants cannot be
made to last indefinitely. Their purpose is to provide temporary
internal support and fixation while fusion mass is consolidating
or fracture is healing, or for the palliative reconstruction of
the tumor patients. These types of implants are more likely to
fail if no bone graft is used, if a pseudarthrosis develops, or if
patients have severe or multiple preoperative curves.
3. The surgeon may remove these implants after bone fusion
occurs. In some cases, removal is indicated because the
implants are not intended to transfer or to support forces
developed during normal activities. The possibility of a second
surgical procedure must be discussed with the patient, and the
risks associated with a second surgical procedure must also
be discussed. If the implants do break, the decision to remove
them must be made by the physician who must consider
the condition of the patient and the risks associated with the
presence of the broken implant.
4. 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 can
not be expected to support the spine indefinitely and will fail
in any of several modes. These modes may include bone-
metal, bone-cement and cement-metal interface failure, implant
fracture, or bone failure.
5. 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.
6. Until X-rays confirm the maturation of the fusion mass or
healed fracture, external immobilization (such as bracing or
casting) is recommended.
7. 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.
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2018-03-09 04:03:33