MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-01-09 for ADJUSTABLE DRILL BIT & ADJUSTABLE STOP * 871-606 & 871-614 manufactured by Sofamor Danek.
[18439801]
Intraoperatively, surgeon experienced difficulty using the drill bit and drill stop. Postoperatively, the pt showed a partial deficit of left c5, but has now regained neurologic function.
Patient Sequence No: 1, Text Type: D, B5
[18693427]
Mfr date for the 981-614 was 8/12/94. Both items were found to meet product specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-1997-00001 |
| MDR Report Key | 61514 |
| Report Source | 05 |
| Date Received | 1997-01-09 |
| Date of Report | 1997-01-09 |
| Date of Event | 1996-12-09 |
| Date Facility Aware | 1997-01-06 |
| Report Date | 1997-01-09 |
| Device Manufacturer Date | 1994-05-01 |
| Date Added to Maude | 1997-01-14 |
| 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 | ADJUSTABLE DRILL BIT & ADJUSTABLE STOP |
| Generic Name | DRILL BIT & STOP |
| Product Code | HXY |
| Date Received | 1997-01-09 |
| Model Number | * |
| Catalog Number | 871-606 & 871-614 |
| Lot Number | * |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 61865 |
| Manufacturer | SOFAMOR DANEK |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-01-09 |