MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-12-18 for BRUNS CURETTE SIZE 000 OS997-001 manufactured by E. G. Medicon.
[38964]
The tip of the curette fractured off during use on a spinal fusion procedure. The fractured tip was retrieved from the wound site. There was no reported permanent impairment of body function or structure as a result of the fractured off tip of the curette.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416557-1996-00013 |
| MDR Report Key | 57918 |
| Report Source | 05,06 |
| Date Received | 1996-12-18 |
| Date of Report | 1996-12-17 |
| Date Facility Aware | 1996-12-04 |
| Report Date | 1996-12-17 |
| Date Reported to Mfgr | 1996-12-17 |
| Date Mfgr Received | 1996-12-17 |
| Device Manufacturer Date | 1996-01-01 |
| Date Added to Maude | 1996-12-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRUNS CURETTE SIZE 000 |
| Generic Name | BONE CURETTE |
| Product Code | HTF |
| Date Received | 1996-12-18 |
| Returned To Mfg | 1996-12-17 |
| Model Number | OS997-001 |
| Catalog Number | OS997-001 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 58407 |
| Manufacturer | E. G. MEDICON |
| Manufacturer Address | GAENSAECK 15 TUTTINGEN GM D-78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-12-18 |