FDA Adverse Event
Other
Summary report: N
WRIST ARTHRODESIS NAIL SYSTEM
MDR report key: 3853764
·
Received May 30, 2014
Report
- Report Number
- 3006742481-2014-00001
- Event Type
- Other
- Date Received
- May 30, 2014
- Date of Event
- May 1, 2014
- Report Date
- May 28, 2014
- Manufacturer
- SKELETAL DYNAMICS LLC
- Product Code
- HSB
- PMA / PMN Number
- K092720
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. PHYSICIAN REPORTING THE EVENT IS DIFFERENT THAN THE PHYSICIAN THAT PERFORMED THE ORIGINAL IMPLANT TWO YEARS PRIOR. THE IMPLANT WAS EXPLANTED REVISION SURGERY.
Description of Event or Problem · 1
IMPLATE CONSTRUCT WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319772 | WRIST ARTHRODESIS NAIL SYSTEM | NONE | HSB | SKELETAL DYNAMICS LLC | IMPLATE NAIL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other |