B.Braun AESCULAP S4 Mode D'emploi page 36

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S Spinal System
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The S Spinal System is not intended to be used without bone
graft which is required to provide additional spinal support. Use
of this product without bone graft or in cases that develop into a
non-union will eventually be unsuccessful. A successful result is
not always achieved in every surgical case. No posterior spinal
fixation system can withstand body loads without the support of
bone. In the event that bone is not provided to facilitate fusion,
bending, loosening, disassembling, and/or breakage of the im-
plants will eventually occur.
The patients should be made aware that a successful result, as
defined by reduced pain, increased function, and the establish-
ment of solid fusion, is not always achieved in every surgical case.
Proper patient selection will greatly effect the results. Patients
who smoke have shown to have an increased incidence of non-
union. These patients should be informed of this increased risk
and counseled to discontinue tobacco use prior to and immedi-
ately after surgery. Obese, malnourished, and/or alcohol abuse
patients are also poor candidates for spinal fusion. Patients with
poor muscle tone and bone quality and/or nerve paralysis are also
poor candidates for spinal fusion.
In addition to the above specified warnings and precautions, gen-
eral surgical risks should be explained to the patient prior to sur-
gery.
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