FDA Adverse Event
Other
Summary report: N
WRIST ARTHRODESIS NAIL SYSTEM
MDR report key: 2466740
·
Received February 14, 2012
Report
- Report Number
- 3006742481-2012-00001
- Event Type
- Other
- Date Received
- February 14, 2012
- Date of Event
- February 3, 2012
- Report Date
- February 13, 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
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PHYSICIAN INDICATED THAT DEVICE FUNCTIONED AS EXPECTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF MANUFACTURING RECORDS DEMONSTRATES THAT ALL MATERIALS MET RELEASE CRITERIA.
Description of Event or Problem · 1
UNICORTICAL SCREW WAS EXPLANTED DUE TO LOOSENING. 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 | UNICORTICAL SCREW | AZ0710055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |