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 |