MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-31 for JOKER PERIOSTEAL ELEVATOR manufactured by Unknown.
[21439]
During surgery, the tip of the periostal elevator broke off. X-ray revealed tip in the open wound. Tip was removed prior to closure. No adverse outcomes due to this event were observed by the pt's physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 30587 |
| MDR Report Key | 30587 |
| Date Received | 1996-01-31 |
| Date of Report | 1995-12-07 |
| Date of Event | 1995-11-16 |
| Date Facility Aware | 1995-11-16 |
| Report Date | 1995-12-07 |
| Date Added to Maude | 1996-03-04 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JOKER PERIOSTEAL ELEVATOR |
| Product Code | GEG |
| Date Received | 1996-01-31 |
| Model Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 31647 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1996-01-31 |