MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-11-15 for LINVATEC * 24.1005 manufactured by Linvatec Corp.
[16820788]
Tip of the 3mm open currette broke during surgery, requiring the pt to have an arthrotomy for tip retrieval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1020438 |
| MDR Report Key | 305060 |
| Date Received | 2000-11-15 |
| Date of Report | 2000-10-31 |
| Date of Event | 2000-10-25 |
| Date Added to Maude | 2000-11-20 |
| 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 | LINVATEC |
| Generic Name | 3MM OPEN CURRETTE |
| Product Code | FZS |
| Date Received | 2000-11-15 |
| Model Number | * |
| Catalog Number | 24.1005 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 295231 |
| Manufacturer | LINVATEC CORP |
| Manufacturer Address | 11311 CONCEPT BLVD LARGO FL 33773 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-11-15 |