MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-08-19 for BRUN BONE CURETTE-ANGLED CUP 3676 * manufactured by Zimmer, Inc..
[15004558]
Tip of curette broke off and lodged in inferior pouch of shoulder capsule. (verified by x-ray). Surgeon unable to retrieve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017011 |
| MDR Report Key | 236834 |
| Date Received | 1999-08-19 |
| Date of Report | 1999-08-18 |
| Date of Event | 1999-08-17 |
| Date Added to Maude | 1999-08-25 |
| 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 |
| 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 | BRUN BONE CURETTE-ANGLED CUP |
| Generic Name | BONE CURETTE |
| Product Code | FZS |
| Date Received | 1999-08-19 |
| Model Number | 3676 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 229514 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | 345 E MAIN ST WARSAW IN 46580 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-08-19 |