B.Braun AESCULAP S4 Mode D'emploi page 42

Postoperative
1. Implant removal must be considered after fusion has oc-
curred due to the possibility of implant loosening, fracture
or corrosion.
2. The risk and benefit of a second surgical procedure must be
evaluated carefully. The surgeon is expected to supply post-
operative care and management instructions to the patient.
The patient should be advised that non-compliance with
postoperative instructions could lead to poor results, in-
cluding implant failure.
3. The patient must be adequately instructed regarding the
risks and limitations of this implant system, and the patient
must be made aware that this system is not expected to
support the spine if fusion does not occur.
4. The patient must be made aware of the risk of failure of the
implant if fusion does not occur. Additional surgeries may
be required if fusion does not occur and implant failure oc-
curs.
5. Patient must be instructed on the physical limitations that
are required to avoid placing excessive stress on the im-
plants causing implant failure or delays in recovery.
6. The patient must be informed that the risks of multiple
complications do exist.
7. Components of this system are only intended to support the
spine during the period required to achieve solid spinal fu-
sion. The device will eventually fail if fusion does not occur.
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4
S Spinal System