FDA Adverse Event
Other
Summary report: N
RE-MOTION TOTAL WRIST SYSTEM IMPLANTS
MDR report key: 909912
·
Received September 7, 2007
Report
- Report Number
- 3003640913-2007-00005
- Event Type
- Other
- Date Received
- September 7, 2007
- Date of Event
- July 16, 2007
- Report Date
- September 5, 2007
- Manufacturer
- SMALL BONE INNOVATIONS, INC.
- Product Code
- KWN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MEDICAL REVIEW OF CLINICAL NOTES SHOW THE PATIENT'S PREVIOUS SURGICAL PROCEDURES (CAPSULODESIS AND PROXIMAL ROW CARPECTOMY) PRIOR TO THE TOTAL WRIST IMPLANT, AND THE TOTAL WRIST IMPLANT COULD NOT ELIMINATE PAIN DUE TO WRIST MOTION. THE FINAL OPTION WAS TO FUSE THE WRIST. REVIEW OF X-RAY POST-OP REVEALS BROKEN CARPAL SCREW LIKELY THE RESULT OF PLACEMENT IN ANATOMY COMPLICATED BY PREVIOUS SURGERIES. MODEL# WA/R-RS, LOT# 35899005.
Description of Event or Problem · 1
TOTAL WRIST IMPLANT WAS REMOVED DUE TO PAIN AND THE WRIST WAS FUSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RE-MOTION TOTAL WRIST SYSTEM IMPLANTS | WRIST PROSTHESIS | KWN | SMALL BONE INNOVATIONS, INC. | WA/C-S | 35899007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other |