FDA Adverse Event
Malfunction
Summary report: N
LOCKING SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE)
MDR report key: 4305721
·
Received December 8, 2014
Report
- Report Number
- 0008010177-2014-00340
- Event Type
- Malfunction
- Date Received
- December 8, 2014
- Date of Event
- November 12, 2014
- Report Date
- November 12, 2014
- Manufacturer
- STRYKER LEIBINGER FREIBURG
- Product Code
- JEY
- PMA / PMN Number
- K022185
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. COMPANY REPRESENTATIVE WAS UNABLE TO ATTAIN DEVICE FOR RETURN.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE INSERTING A LOCKING SCREW (50-20512), IT SNAPPED OFF AT THE HEAD. THE HEAD OF THE SCREW IS NOT ABLE TO BE RETURNED, AND THE REMAINING SCREW THREAD REMAINED IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 791959 | LOCKING SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE) | IMPLANT | JEY | STRYKER LEIBINGER FREIBURG | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |