Depuy Synthes EXPEDIUM SFX Handbuch Seite 11

as normal healthy bone and could loosen, bend and/or
break if excessive demands are placed on it, especially in
the absence of complete bone healing. Implants displaced
or damaged by improper activities may migrate and
damage the nerves or blood vessels. An active, debilitated,
or demented patient who cannot properly use weight-
supporting devices may be particularly at risk during
postoperative rehabilitation.
POSSIBLE ADVERSE EFFECTS
1. Bending or fracture of implant.
2. Loosening of the implant.
3. Metal sensitivity, or allergic reaction to a foreign body.
4. Infection, early or late.
5. Nonunion, delayed union.
6. Decrease in bone density due to stress shielding.
7. Pain, discomfort, or abnormal sensations due to the
presence of the device.
8. Nerve damage due to surgical trauma or presence of the
device. Neurological difficulties including bowel and/or
bladder dysfunction, impotence, retrograde ejaculation,
and paraesthesia.
9. Bursitis.
10. Paralysis.
11. Dural tears experienced during surgery could result in the
need for further surgery for dural repair, a chronic CSF
leak or fistula, and possible meningitis.
12. Death.
13. Vascular damage due to surgical trauma or presence of
the device. Vascular damage could result in catastrophic
or fatal bleeding. Malpositioned implants adjacent to large
arteries or veins could erode these vessels and cause
catastrophic bleeding in the late postoperative period.
14. Screw back out, possibly leading to implant loosening,
and/or reoperation for device removal.
15. Damage to lymphatic vessels and/or lymphatic fluid
exudation.
16. Spinal cord impingement or damage.
17. Fracture of bony structures.
18. Degenerative changes or instability in segments adjacent
to fused vertebral levels.
LIMITED WARRANTY AND DISCLAIMER
PRODUCTS FROM DEPUY SYNTHES PRODUCTS, INC. ARE
SOLD WITH A LIMITED WARRANTY TO THE ORIGINAL
PURCHASER AGAINST DEFECTS IN WORKMANSHIP AND
MATERIALS. ANY OTHER EXPRESS OR IMPLIED WARRAN-
TIES, INCLUDING WARRANTIES OF MERCHANTABILITY
OR FITNESS, ARE HEREBY DISCLAIMED.
IF MORE THAN TWO YEARS HAVE ELAPSED BETWEEN
THE DATE OF ISSUE/REVISION OF THIS INSERT AND THE
DATE OF CONSULTATION, CONTACT DEPUY SYNTHES
SPINE FOR CURRENT INFORMATION AT +1-800-365-6633
OR AT +1-508-880-8100.
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