FDA Adverse Event
Malfunction
Summary report: N
WRISTLOC COLLES FRACTURE KIT
MDR report key: 1030806
·
Received April 17, 2008
Report
- Report Number
- 2242816-2008-00049
- Event Type
- Malfunction
- Date Received
- April 17, 2008
- Date of Event
- March 4, 2008
- Report Date
- March 26, 2008
- Manufacturer
- EBI
- Product Code
- LXT
- PMA / PMN Number
- K001760
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DHR WAS REVIEWED FOR THE REPORTED DEVICE AND NO DISCREPANCIES WERE OBSERVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SET SCREW WAS FOUND TO NOT HAVE A RECESSED HEX INSERT IN THE SCREW HEAD FOR THE SCREWDRIVER TO ENGAGE WITH. AN ADD'L SCREW WAS AVAILABLE AND WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WRISTLOC COLLES FRACTURE KIT | LXT | EBI | 357570 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |