MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-05-24 for SYNTHES USA 399.40 MANUFACTURED ON 2-5-99 manufactured by Synthes (usa).
[15703807]
Periosteal elevator broke during procedure. While removing a small bone plate, mallet used. Handle cracked. 3 small pieces retrieved. No adverse effect on pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1018975 |
| MDR Report Key | 279145 |
| Date Received | 2000-05-24 |
| Date of Report | 2000-04-17 |
| Date of Event | 2000-04-17 |
| Date Added to Maude | 2000-05-26 |
| 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 |
| 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 | SYNTHES USA |
| Generic Name | PERIOSTEAL ELEVATOR |
| Product Code | GEG |
| Date Received | 2000-05-24 |
| Returned To Mfg | 2000-05-22 |
| Model Number | 399.40 |
| Catalog Number | MANUFACTURED ON 2-5-99 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 270160 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1690 RUSSELL RD. PO BOX 1766 PAOLI PA 19301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-05-24 |