FDA Adverse Event
Injury
Summary report: N
EVOLVE MODULAR RADIAL HEAD COMPONENT
MDR report key: 2171895
·
Received April 11, 2007
Report
- Report Number
- 2171895
- Event Type
- Injury
- Date Received
- April 11, 2007
- Date of Event
- November 30, 2006
- Report Date
- April 10, 2007
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KWI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE PT SUSTAINED A FRACTURE OF THE LEFT RADIAL HEAD ON (B)(6) 2006. ON (B)(6) 2006, THE PT UNDERWENT SURGERY, ORIF (OPEN REDUCTION AND INTERNAL FIXATION) AND A RADIAL IMPLANT WAS UTILIZED. AS A RESULT OF CONTINUED PAIN, THE PT WAS RETURNED TO SURGERY ON (B)(6) 2006. AT THE TIME OF SURGERY, ATTEMPTS WERE MADE TO TEST THE LOCKING MECHANISM OF THE IMPLANT. FAILURE TO SUCCEED IN LOCKING RESULTED IN REMOVAL OF THE IMPLANT AND PLACEMENT OF A NEW IMPLANT OF THE SAME SIZE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EVOLVE MODULAR RADIAL HEAD COMPONENT | RADIAL HEAD | KWI | WRIGHT MEDICAL TECHNOLOGY, INC. | 496-S065 | 106378775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |