FDA Adverse Event
Other
Summary report: N
IMPLATE WRIST ARTHRODESIS SYSTEM
MDR report key: 3349725
·
Received September 4, 2013
Report
- Report Number
- 3006742481-2013-00006
- Event Type
- Other
- Date Received
- September 4, 2013
- Date of Event
- August 7, 2013
- Report Date
- September 3, 2013
- Manufacturer
- SKELETAL DYNAMICS LLC
- Product Code
- KWI
- PMA / PMN Number
- K092720
- Adverse Event
- 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, THOUGH AN INFECTION WAS REPORTED. REVIEW OF MFG RECORDS DEMONSTRATES THAT ALL MATERIALS MET RELEASE CRITERIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT A WRIST ARTHRODESIS CONSTRUCT WAS REMOVED BECAUSE OF AN INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 437637 | IMPLATE WRIST ARTHRODESIS SYSTEM | NONE | KWI | SKELETAL DYNAMICS LLC | AZ0411001, AZ0910001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |