FDA Adverse Event
Malfunction
Summary report: N
FULLY THREADED CANCELLOUS SCREW
MDR report key: 3980469
·
Received June 5, 2014
Report
- Report Number
- 2648920-2014-00146
- Event Type
- Malfunction
- Date Received
- June 5, 2014
- Report Date
- May 12, 2014
- Manufacturer
- ZIMMER
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT INCORRECT SCREWS WERE PACKAGED IN CANCELLOUS SCREWS' PACKAGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329866 | FULLY THREADED CANCELLOUS SCREW | HWC | ZIMMER | 62629432 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |