BIOSURE REGEN SCREW 5 X 20MM Adverse Event — Malfunction (MDR 1219602-2020-00696)
BIOSURE REGEN SCREW 5 X 20MM Adverse Event — Malfunction (MDR 1219602-2020-00696) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BIOSURE REGEN SCREW 5 X 20MM; Generic name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE; Manufacturer: SMITH & NEPHEW, INC..
| Device | BIOSURE REGEN SCREW 5 X 20MM |
|---|---|
| Generic name | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE |
| Manufacturer | SMITH & NEPHEW, INC. |
| Report number | 1219602-2020-00696 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | H10: THE REPORTED 5X20 BIOSURE REGENESORB SCREW, USED IN TREATMENT, HAS NOT BEEN RETURNED FOR EVALUATION. WITHOUT THE REPORTED PRODUCT A VISUAL EVALUATION CANNOT BE PERFORMED AND THE CUSTOMERS COMPLAINT CANNOT BE CONFIRMED. FROM THE INFORMATION PROVIDED, THE SCREW WOULD NOT FIXATE IN THE TUNNEL. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE. A REVIEW OF THE MANUFACTURING AND COMPLAINT R |
| Source | openFDA MAUDE (device adverse events) |
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