FDA Adverse Event
Injury
Summary report: N
PLATE
MDR report key: 2943983
·
Received February 5, 2013
Report
- Report Number
- 1020279-2013-00071
- Event Type
- Injury
- Date Received
- February 5, 2013
- Date of Event
- January 22, 2013
- Report Date
- February 4, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HRS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FRACTURED HARDWARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 48626 | PLATE | PLATE | HRS | SMITH & NEPHEW, INC. | 10HM18763 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |