FDA Adverse Event
Injury
Summary report: N
VHS LAG SCREW
MDR report key: 225530
·
Received May 27, 1999
Report
- Report Number
- 1825034-1999-00058
- Event Type
- Injury
- Date Received
- May 27, 1999
- Date of Event
- February 25, 1999
- Report Date
- May 26, 1999
- Manufacturer
- BIOMET, INC.
- Product Code
- HRS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
ANGLE PLANE WAS IMPLANTED ON 11/16/1998. REMOVAL AND REPLACEMENT OF THE DEVICE OCCURRED ON 2/25/1999, DUE TO THE COLLAPSE OF THE PLATE COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VHS LAG SCREW Implant | FIXATION, TRAUMA, COMP. | HRS | BIOMET, INC. | NA | 683010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |