MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-20 for ULTRA DRIVE 423871 manufactured by Biomet Orthopedics.
[660332]
Ultra drive 7. 0 mm disk drive tool being used to remove cement from right femur shaft, broke off at the tip x2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003141 |
| MDR Report Key | 885286 |
| Date Received | 2007-07-20 |
| Date of Report | 2007-07-20 |
| Date of Event | 2007-07-11 |
| Date Added to Maude | 2007-08-08 |
| 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 | ULTRA DRIVE |
| Generic Name | 7.0 MM DISK DRILL TOOL |
| Product Code | LZV |
| Date Received | 2007-07-20 |
| Model Number | 423871 |
| Lot Number | 779930 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 867489 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 WEST BELL DR PO BOX 587 WARSAW IN 46581 US |
| Brand Name | ULTRA DRIVE |
| Generic Name | 7.0 MM DISK DRILL TOOL |
| Product Code | LZV |
| Date Received | 2007-07-20 |
| Model Number | 423871 |
| Lot Number | 860100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 2 |
| Device Event Key | 867490 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 WEST BELL DR PO BOX 587 WARSAW MO 46581 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2007-07-20 |