FDA Adverse Event
Other
Summary report: N
DARCO SCREW
MDR report key: 1620122
·
Received February 24, 2010
Report
- Report Number
- 1043534-2010-00054
- Event Type
- Other
- Date Received
- February 24, 2010
- Date of Event
- December 11, 2009
- Report Date
- February 24, 2010
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO REPORT HAS BEEN RECEIVED FROM THE SURGEON. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME REPORT AS 1043534-2010-00055.
Description of Event or Problem · 1
ALLEGEDLY THE BLUE FROM THE SCREWS HAVE TRANSFERRED TO THE SURROUNDING TISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DARCO SCREW | SMALL JOINT COMPONENT | HWC | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |