FDA Adverse Event
Other
Summary report: N
WRIST ARTHRODESIS NAIL SYSTEM
MDR report key: 2712939
·
Received August 17, 2012
Report
- Report Number
- 3006742481-2012-00005
- Event Type
- Other
- Date Received
- August 17, 2012
- Date of Event
- July 19, 2012
- Report Date
- August 17, 2012
- 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 THE MANUFACTURING 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 |
|---|---|---|---|---|---|---|---|
| 1 | WRIST ARTHRODESIS NAIL SYSTEM | NONE | HSB | SKELETAL DYNAMICS LLC | UNICORTICAL SCREW | AZ0810011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |