FDA Adverse Event
Injury
Summary report: N
PERI-LOC
MDR report key: 2940795
·
Received November 15, 2006
Report
- Report Number
- 1020279-2006-00649
- Event Type
- Injury
- Date Received
- November 15, 2006
- Date of Event
- October 27, 2006
- Report Date
- November 15, 2006
- Manufacturer
- SMITH & NEPHEW, INC., ORTHOPAEDICS DIV.
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE UNDER EVALUATION.
Description of Event or Problem · 1
PLATE BENT REQUIRING REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERI-LOC | INTERNAL FIXATION PLATE | HRS | SMITH & NEPHEW, INC., ORTHOPAEDICS DIV. | NA | 05CM01849 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Hospitalization| R |