FDA Adverse Event
Injury
Summary report: N
RE-MOTION TOTAL WRIST
MDR report key: 3231366
·
Received July 15, 2013
Report
- Report Number
- 3003640913-2013-00032
- Event Type
- Injury
- Date Received
- July 15, 2013
- Date of Event
- June 11, 2013
- Report Date
- July 15, 2013
- Manufacturer
- SMALL BONE INNOVATIONS, INC.
- Product Code
- JWJ
- PMA / PMN Number
- K021859
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PATIENT HAD WRIST IMPLANT REVISED TO FUSION AFTER 3 YEARS. UPON REVIEW OF PATIENT'S FILMS, BONE LUCENCY IS NOTED WHERE THE RADIAL SCREW PENETRATES UP INTO THE SECOND METACARPAL, AND AROUND THE RADIAL COMPONENT. VISUAL EVALUATION SHOWS NO ANOMALIES OTHER THAN THE MARKS FROM REMOVAL. D4 ADDITIONAL INFORMATION: MODEL #: WA/C-M; CATALOG #: WA/S-18; LOT #:15885, 15884, 14885; EXPIRATION DATE: 09/2014, 01/2015, 03/2015. ADDITIONAL INFORMATION: 09/1999, 01/2010, 03/2010.
Description of Event or Problem · 1
PATIENT HAD RE-MOTION TOTAL WRIST REVISED TO FUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 327788 | RE-MOTION TOTAL WRIST | PROSTHESIS, WRIST, 3 PART METAL-PLASTIC | JWJ | SMALL BONE INNOVATIONS, INC. | WA/R-RM | 15862 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |