FDA Adverse Event
Injury
Summary report: N
PERILOC ANKLE FUSION TTC PLATE SCREW
MDR report key: 2882436
·
Received December 20, 2012
Report
- Report Number
- 1020279-2012-00696
- Event Type
- Injury
- Date Received
- December 20, 2012
- Report Date
- November 30, 2012
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REVISION SURGERY WAS REPORTED DUE TO SCREW BACK-OUT ISSUES WITH THE PERILOC ANKLE FUSION TTC PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERILOC ANKLE FUSION TTC PLATE SCREW | SCREW | HWC | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |