Johnson & Johnson DePuy Synthes ISOLA Bedienungsanleitung Seite 10

migration of implants or if pulsatile erosion of the vessels
occurs because of close apposition of the implants.
POSSIBLE ADVERSE EFFECTS
Potential complications and adverse effects with these
systems are similar to those with other spinal instrumentation
systems. These complications may include:
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.
Additional Possible Adverse Effects
for Anterior ISOLA Spine System
19. Loss of normal spinal contours.
20. Cessation of growth of the fused portion of the spine.
21. Pulmonary complications.
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
WARRANTIES, INCLUDING WARRANTIES OF MERCHANT-
ABILITY 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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