FDA Adverse Event
Other
Summary report: N
WRIST ARTHRODESIS NAIL SYSTEM
MDR report key: 2996292
·
Received February 12, 2013
Report
- Report Number
- 3006742481-2013-00001
- Event Type
- Other
- Date Received
- February 12, 2013
- Date of Event
- January 14, 2013
- Report Date
- February 11, 2013
- Manufacturer
- SKELETAL DYNAMICS LLC
- Product Code
- HSB
- PMA / PMN Number
- K092720
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. PHYSICIAN INDICATED DEVICE FUNCTIONED AS EXPECTED. REVIEW OF MFG RECORDS DEMONSTRATES THAT ALL MATERIALS MET RELEASE CRITERIA.
Description of Event or Problem · 1
UNICORTICAL SCREW WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 61347 | WRIST ARTHRODESIS NAIL SYSTEM | NONE | HSB | SKELETAL DYNAMICS LLC | UNICORTICAL SCREW | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |