FDA Adverse Event
Other
Summary report: N
CHARLOTTE MUC SCREW
MDR report key: 1239281
·
Received August 15, 2008
Report
- Report Number
- 1043534-2008-00182
- Event Type
- Other
- Date Received
- August 15, 2008
- Date of Event
- June 4, 2008
- Report Date
- July 22, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HWC
- PMA / PMN Number
- K043102
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. ADD'L INFO HAS BEEN REQUESTED FROM THE SURGEON AND THE USER FACILITY. TRENDS WILL BE EVALUATED. A MEDWATCH 3500A WAS REC'D FROM THE USER FACILITY AND IS ATTACHED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETED. THIS IS A PRODUCT MALFUNCTION.
Description of Event or Problem · 1
ALLEGEDLY, SCREW HIT OTHER IMPLANT UPON INSERTION. HEAD BROKE OFF SCREW. REMAINING PORTION OF SCREW FULLY EMBEDDED IN BONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHARLOTTE MUC SCREW | * | HWC | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | 037416579 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |