MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-12-05 for manufactured by .
[201652]
During acl repair the screw broke in half while implanting it into femur. Attempts to remove the screw was unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613278-2000-00028 |
| MDR Report Key | 307866 |
| Report Source | 06 |
| Date Received | 2000-12-05 |
| Date of Event | 2000-03-08 |
| Date Mfgr Received | 2000-05-02 |
| Date Added to Maude | 2000-12-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1777 SENTRY PKWY WEST |
| Manufacturer City | GWYNEDD HALL PA 19422 |
| Manufacturer Country | US |
| Manufacturer Postal | 19422 |
| Manufacturer Phone | 3583316560 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | MBJ |
| Date Received | 2000-12-05 |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 264382 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-12-05 |