MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-10-17 for STRYKER * 2989789502 manufactured by Stryker.
[199543]
Saw guard broke in half during surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1020196 |
| MDR Report Key | 301062 |
| Date Received | 2000-10-17 |
| Date of Report | 2000-10-17 |
| Date of Event | 2000-08-24 |
| Date Added to Maude | 2000-10-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER |
| Generic Name | SAW GUARD |
| Product Code | DWI |
| Date Received | 2000-10-17 |
| Model Number | * |
| Catalog Number | 2989789502 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 291382 |
| Manufacturer | STRYKER |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-10-17 |