FDA Adverse Event
Injury
Summary report: N
VHS VARIABLE ANGLE PLATE
MDR report key: 294823
·
Received September 7, 2000
Report
- Report Number
- 1825034-2000-00065
- Event Type
- Injury
- Date Received
- September 7, 2000
- Date of Event
- July 27, 2000
- Report Date
- September 6, 2000
- Manufacturer
- BIOMET, INC.
- Product Code
- HRS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
VHS PLATE AND LAG SCREW IMPLANTED IN 1999.
Description of Event or Problem · 1
VHS PLATE AND LAG SCREW IMPLANTED IN 1999. COMPONENTS WERE REMOVED IN 2000, DUE TO IN-VIVO CHANGE OF PLATE ANGLE. FRACTURE WAS NON-UNION AND HARDWARE WAS REPLACED WITH A FIXED ANGLE PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VHS VARIABLE ANGLE PLATE | FIXATION, TRAUMA, COMP. | HRS | BIOMET, INC. | NA | 532740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| R |