FDA Adverse Event
Other
Summary report: N
WRIST ARTHRODESIS NAIL SYSTEM
MDR report key: 2591880
·
Received May 18, 2012
Report
- Report Number
- 3006742481-2012-00003
- Event Type
- Other
- Date Received
- May 18, 2012
- Date of Event
- April 19, 2012
- Report Date
- May 18, 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. REVIEW OF MFG RECORDS DEMONSTRATES THAT ALL MATERIALS MET RELEASE CRITERIA.
Description of Event or Problem · 1
METACARPAL NAIL WAS EXPLANTED DUE TO INFECTION. FOREIGN FLUID REPORTED TO HAVE BEEN USED WITH BONE GRAFT. NO INDICATION OF PRODUCT MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WRIST ARTHRODESIS NAIL SYSTEM | NONE | HSB | SKELETAL DYNAMICS, LLC. | METACARPAL NAIL | AZ0311001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |