FDA Adverse Event
Other
Summary report: N
WRIST ARTHRODESIS NAIL SYSTEM
MDR report key: 3565586
·
Received December 30, 2013
Report
- Report Number
- 3006742481-2013-00009
- Event Type
- Other
- Date Received
- December 30, 2013
- Date of Event
- November 21, 2013
- Report Date
- December 27, 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 EVENT. REVIEW OF MFG RECORDS DEMONSTRATES THAT ALL MATERIALS MET RELEASE CRITERIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT DEVICE WAS REMOVED. IT WAS ALSO REPORTED THAT PT HAD WORK RELATED INJURY, PRIOR SURGERY, AND DEVELOPMENT OF SIGNIFICANT PHYSIOLOGICAL CHANGES PRIOR TO DEVICE IMPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 680217 | WRIST ARTHRODESIS NAIL SYSTEM | NONE | HSB | SKELETAL DYNAMICS LLC | AZ0311001 AZ1110010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other |