FDA Adverse Event
Other
Summary report: N
ALIGN RADIAL HEAD PROSTHESES
MDR report key: 3011163
·
Received March 15, 2013
Report
- Report Number
- 3006742481-2013-00003
- Event Type
- Other
- Date Received
- March 15, 2013
- Date of Event
- February 7, 2013
- Report Date
- March 7, 2013
- Manufacturer
- SKELETAL DYNAMICS, LLC
- Product Code
- KWI
- PMA / PMN Number
- K092721
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED FOR EVAL. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. SURGEON INDICATED DEVICE FUNCTIONED AS EXPECTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A RADIAL HEAD IMPLANT WAS REMOVED AT THE REQUEST OF THE PT DUE TO PAIN AND A DESIRE TO NOT HAVE AN IMPLANT IN THE BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110259 | ALIGN RADIAL HEAD PROSTHESES | NONE | KWI | SKELETAL DYNAMICS, LLC | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |