FDA Adverse Event
Injury
Summary report: N
PERI-LOC
MDR report key: 1873349
·
Received October 19, 2010
Report
- Report Number
- 1020279-2010-00290
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- August 18, 2010
- Report Date
- October 7, 2010
- Manufacturer
- SMITH & NEPHEW, INC
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER IMPLANTATION THE SCREWS BACKED OUT OF THE PLATE. A REVISION SURGERY WAS PERFORMED TO CORRECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERI-LOC | PLATE | HRS | SMITH & NEPHEW, INC | 06EM00481 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| R | 71826034/ (B)(4)| 71827032/ (B)(4)| 71827066/ (B)(4)| 71827060/ (B)(4)| 71827070/ (B)(4)| 71827036/ (B)(4) |