FDA Adverse Event
Other
Summary report: N
BIOMET
MDR report key: 380226
·
Received March 5, 2002
Report
- Report Number
- 380226
- Event Type
- Other
- Date Received
- March 5, 2002
- Date of Event
- January 26, 2002
- Report Date
- February 22, 2002
- Manufacturer
- BIOMET, INC.
- Product Code
- HWC
- Report Source
- User Facility report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
PT TO OR AFTER ADMITTED FOR COMPLAINT OF PAIN AFTER HISTORY OF ORIF IN 2001. FOUND TO HAVE FRACTURE OF LEG. SCREW AT NON-UNION RIGHT FEMUR. TO OR FOR REMOVAL AND REPLACEMENT OF FRACTURED LAG SCREW COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMET | LAG SCREW/COMPRESSION SCREW | HWC | BIOMET, INC. | UNK | 555520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |