Depuy Synthes VIPER PRIME Gebrauchsanweisung Seite 11

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.
INDICATIONS
The VIPER System is intended to provide immobilization and stabilization of spinal segments in
skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or
deformities of the thoracic, lumbar and sacral spine.
The VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation for the
following indications: degenerative disc disease (defined as back pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma
(i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
tumor, pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used in a posterior percutaneous approach with MIS instrumentation, the VIPER System
is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications:
degenerative disc disease (defined as back pain of discogenic origin with degeneration of the
disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture
or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor,
pseudarthrosis; and failed previous fusion in skeletally mature patients.
CONTRAINDICATIONS
• Disease conditions that have been shown to be safely and predictably managed without the use of
internal fixation devices are relative contraindications to the use of these devices.
• Active systemic infection or infection localized to the site of the proposed implantation are
contraindications to implantation.
• Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of
spinal anchors and thus preclude the use of this or any other spinal instrumentation system.
• Any entity or condition that totally precludes the possibility of fusion, i.e., cancer, kidney dialysis, or
osteopenia is a relative contraindication. Other relative contraindications include obesity, certain
degenerative diseases, and foreign body sensitivity. In addition, the patient's occupation or activity
level or mental capacity may be relative contraindications to this surgery. Specifically, patients who
because of their occupation or lifestyle, or because of conditions such as mental illness,
alcoholism, or drug abuse, may place undue stresses on the implant during bony healing and may
be at higher risk for implant failure.
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.
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