FDA Adverse Event
Other
Summary report: N
CHARLOTTE CLAW SCREW
MDR report key: 1032485
·
Received April 14, 2008
Report
- Report Number
- 1043534-2008-00067
- Event Type
- Other
- Date Received
- April 14, 2008
- Date of Event
- March 27, 2008
- Report Date
- March 27, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HRS
- PMA / PMN Number
- K051908
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. A MEDWATCH 3500A HAS NOT BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
ALLEGEDLY SCREW STRIPPED DELAYING SURGERY 30MINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHARLOTTE CLAW SCREW | HRS | WRIGHT MEDICAL TECHNOLOGY, INC. | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |