B.Braun AESCULAP S4 Mode D'emploi page 35

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S Spinal System
The implant can be damaged by spondylolisthesis repositioning
through the clamping screw. Always use the rod persuader for
spondylolisthesis repositioning.
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 mechan-
ical instability or deformity of the thoracic, lumbar, and sacral
spine secondary to degenerative spondylolisthesis with objective
evidence of neurological impairment, fracture, dislocation, scoli-
osis, kyphosis, spinal tumor, and failed previous fusion (pseudar-
throsis). 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 be-
cause this is a technically demanding procedure presenting a risk
of serious injury to the patient.
See Warnings and Precautions, and Complications and Possible
Adverse Effects sections of this package insert for a complete list
of potential risks.
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The S Spinal System should be implanted only by surgeons ex-
perienced in the use of spinal fixation systems. This system
should only be used with instrumentation specifically designed
for this system and the surgeon should be familiar with the sur-
gical technique.
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