FDA Adverse Event
Injury
Summary report: N
IMHS CP SCREW
MDR report key: 2842096
·
Received November 21, 2012
Report
- Report Number
- 1020279-2012-00635
- Event Type
- Injury
- Date Received
- November 21, 2012
- Date of Event
- September 20, 2012
- Report Date
- November 13, 2012
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO BROKEN IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMHS CP SCREW | 4.5MMX36MM | HWC | SMITH & NEPHEW, INC. | 11GM01120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| R |