FDA Adverse Event
Malfunction
Summary report: N
M/DN CORTICAL SCREW
MDR report key: 3061476
·
Received April 10, 2013
Report
- Report Number
- 2648920-2013-00097
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- February 22, 2013
- Report Date
- March 11, 2013
- Manufacturer
- ZIMMER
- Product Code
- HSB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
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 THE SCREW BROKE WHILE INSERTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148247 | M/DN CORTICAL SCREW | HSB | ZIMMER | 60985463 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |