FDA Adverse Event
Malfunction
Summary report: N
KLS BONE REDUCTION CLAMP
MDR report key: 3896484
·
Received June 2, 2014
Report
- Report Number
- 3896484
- Event Type
- Malfunction
- Date Received
- June 2, 2014
- Date of Event
- May 19, 2014
- Report Date
- June 2, 2014
- Manufacturer
- KLS MARTIN LP
- Product Code
- GDJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
REDUCTION FORCEP WAS BEING USED BY SURGEON; RIGHT TIP OF FORCEP BROKE OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322522 | KLS BONE REDUCTION CLAMP | CLAMP | GDJ | KLS MARTIN LP | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |