MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-19 for MINI-REVO * C6114 manufactured by Linvatec.
[46012]
While using the punch to make hole in the bone, the end broke off into the pt. X-rays were performed to determine the location of the tip. The tip of the instrument is embedded in the pt's shoulder and cannot be retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010970 |
| MDR Report Key | 77150 |
| Date Received | 1997-03-19 |
| Date of Report | 1997-03-06 |
| Date of Event | 1997-02-20 |
| Date Added to Maude | 1997-03-21 |
| 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 | MINI-REVO |
| Generic Name | BONE PUNCH |
| Product Code | FCI |
| Date Received | 1997-03-19 |
| Model Number | * |
| Catalog Number | C6114 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 76869 |
| Manufacturer | LINVATEC |
| Manufacturer Address | 11311 CONCEPT BLVD LARGO FL 34647 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-03-19 |