FDA Adverse Event
Injury
Summary report: N
VHS VARIABLE ANGLE PLATE
MDR report key: 381039
·
Received March 8, 2002
Report
- Report Number
- 1825034-2002-00027
- Event Type
- Injury
- Date Received
- March 8, 2002
- Date of Event
- February 4, 2002
- Report Date
- March 6, 2002
- Manufacturer
- BIOMET, INC.
- Product Code
- HRS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FOLLOWING INSTALLATION IN 2001, FOR FIXATION OF LEFT SUBTROCHANTERIC FRACTURE, PERIODIC RADIOGRAPHS NOTED CHANGES IN PLATE ANGLE. HARDWARE WAS REMOVED AND REPLACED IN 2002.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VHS VARIABLE ANGLE PLATE | FIXATION, TRAUMA, COMP. | HRS | BIOMET, INC. | NA | 968420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| R |