B.Braun AESCULAP S4 Mode D'emploi page 32

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S Spinal System
Indications
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The S Spinal System, when used as a pedicle screw fixation sys-
tem, is indicated for use in patients: a) having severe spondylolis-
thesis (Grade 3 and 4) at the L5-S1 joint; b) who are receiving fu-
sion using autogenous graft only; c) who are having the device
fixed or attached to the lumbar or sacral spine; and d) who are
having the device removed after the development of a solid fu-
sion mass. When used for this indication, the fusion mass may
not go above the L5-S1 joint, the levels of pedicle screw fixation
may span from L3 to the sacrum.
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The S Spinal System is a pedicle screw system intended to
provide immobilization and stabilization of spinal segments in
skeletally mature patients as an adjunct to fusion in the
treatment of the following acute and chronic instabilities or
deformities of the thoracic, lumbar, and sacral spine:
degenerative spondylolisthesis with objective evidence of
neurological impairment, fracture, dislocation, scoliosis,
kyphosis, spinal tumor, and failed previous fusion
(pseudarthrosis).
When used as a hook and sacral screw system (other than pedicle
screw fixation system for high grade spondylolisthesis), the
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S Spinal System is intended for use in the treatment of degen-
erative disc disease (as defined by chronic back pain of discogenic
origin with degeneration of the disc confirmed by a history and
radiographic studies), idiopathic scoliosis, spondylolisthesis,
kyphotic or lordotic deformity of the spine, loss of stability due to
tumors, spinal stenosis, vertebral fracture or dislocation,
pseudarthrosis, and previous failed spinal surgery/fusion.
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