FDA Adverse Event
Injury
Summary report: N
PERI-LOC
MDR report key: 1153312
·
Received September 9, 2008
Report
- Report Number
- 1020279-2008-00232
- Event Type
- Injury
- Date Received
- September 9, 2008
- Report Date
- August 4, 2008
- Manufacturer
- SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PATIENT UNDERWENT REVISION SURGERY DUE TO THE PLATE AND SCREW BREAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERI-LOC | INTERNAL FIXATION - PLATE | HRS | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |