FDA Adverse Event
Injury
Summary report: N
PERI-LOC
MDR report key: 1054074
·
Received May 28, 2008
Report
- Report Number
- 1020279-2008-00165
- Event Type
- Injury
- Date Received
- May 28, 2008
- Date of Event
- April 23, 2008
- Report Date
- May 9, 2008
- Manufacturer
- SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FYI. THE PLATE INVOLVED IN THIS INCIDENT WAS RETURNED AND IS CURRENTLY BEING EVALUATED; HOWEVER, THE SCREWS WERE DISCARDED AND WERE NOT RETURNED. SUPPLEMENT WILL BE FILED WHEN RESULTS ARE AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED 3 WEEKS POST-OP DUE TO SCREWS BACKING OUT OF PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERI-LOC | INTERNAL FIXATION - PLATE | HRS | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. | NA | 07HM17465 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization| O |