MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-04-19 for LINVATEC * C8026 manufactured by *.
[16819046]
Upon completion of acl repair an x-ray was taken for placement of screws. The x-ray revealed that a piece of the guide pin that had been utilized was broken off and retained inside the screw on the femur side. Dr notified stated no problem for pt. Defective product report filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1031879 |
| MDR Report Key | 525163 |
| Date Received | 2004-04-19 |
| Date of Report | 2004-04-09 |
| Date of Event | 2004-03-26 |
| Date Added to Maude | 2004-05-18 |
| 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 | 3 |
| 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 | LINVATEC |
| Generic Name | BIOSCREW GUIDE WIRE |
| Product Code | GFC |
| Date Received | 2004-04-19 |
| Model Number | * |
| Catalog Number | C8026 |
| Lot Number | * |
| ID Number | PRODUCT# C8026 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 514291 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-04-19 |