Depuy Synthes VIPER PRIME Gebrauchsanweisung Seite 8

pulmonary embolism, and cardiac embolism. Although the majority of these adverse events
present early within the post-operative period, there have been some reports of diagnoses
beyond a year or more after the procedure.
2. Other reported adverse events for acrylic bone cements intended for use in the spine include:
Leakage of the bone cement beyond the site of its intended application with introduction into the
vascular system resulting in embolism of the lung and/or heart or other clinical sequelae.
3. Bending or fracture of implant.
4. Loosening of the implant. Screw back out, possibly leading to implant loosening, and/or
reoperation for device removal.
5. Metal sensitivity, or allergic reaction to a foreign body.
6. Superficial or deep wound infection, early or late.
7. Nonunion, delayed union.
8. Decrease in bone density due to stress shielding.
9. Pain, discomfort, or abnormal sensations due to the presence of the device.
10. Nerve damage due to surgical trauma or presence of the device. Neurological difficulties
including bowel and/or bladder dysfunction, impotence, retrograde ejaculation, and paraesthesia.
11. Bursitis.
12. Paralysis.
13. 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.
14. 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. Also local
vascular erosion and occlusion may result due to cement use.
15. Damage to lymphatic vessels and/or lymphatic fluid exudation.
16. Spinal cord impingement or damage.
17. Fracture of bony structures. Fracture, degenerative changes or instability in segments adjacent
to fused vertebral levels.
18. Anaphylaxis. Allergic pyrexia
19. Transitory fall in blood pressure.
20. Hypertension or hypotension.
21. Thrombophlebitis.
22. Hemorrhage and hematoma.
23. Cardiac arrythmia.
24. Heterotopic bone formation.
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