MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-18 for W. LORENZE manufactured by Biomet Microfixation.
[1285398]
Pt to the or for a lefort i procedure. During the procedure, a nasal septal chisel was used. After the chisel was used, it noted that the anterior 4th portion was missing. Piece retrieved with x-ray assist. No harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014849 |
| MDR Report Key | 1613690 |
| Date Received | 2010-02-18 |
| Date of Report | 2010-02-18 |
| Date of Event | 2010-01-20 |
| Date Added to Maude | 2010-03-12 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | W. LORENZE |
| Generic Name | NONE |
| Product Code | EML |
| Date Received | 2010-02-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DR. JACKSONVILLE FL 32218248 US 32218 2480 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-18 |