FDA Adverse Event
Injury
Summary report: N
REPIPHYSIS DISTAL FEMUR
MDR report key: 1081322
·
Received July 24, 2008
Report
- Report Number
- 1043534-2008-00167
- Event Type
- Injury
- Date Received
- July 24, 2008
- Date of Event
- June 20, 2008
- Report Date
- July 14, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KRO
- PMA / PMN Number
- K021489
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFO HAS BEEN REQUESTED. TRENDS WILL BE EVALUATED. EVENT DEVICE CODE IS ADDRESSED IN PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN ANOTHER COUNTRY.
Description of Event or Problem · 1
ALLEGEDLY THE IMPLANT WAS NOT ABLE TO BE EXPANDED TO FULL EXPANSION CAPACITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPIPHYSIS DISTAL FEMUR | KRO | WRIGHT MEDICAL TECHNOLOGY, INC. | 105281013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization| R |