FDA Adverse Event
Malfunction
Summary report: N
ORTHOLOC(R) TITANIUM NON-LOCKING SCREW
MDR report key: 6040391
·
Received October 19, 2016
Report
- Report Number
- 1043534-2016-00114
- Event Type
- Malfunction
- Date Received
- October 19, 2016
- Date of Event
- October 11, 2016
- Report Date
- October 19, 2016
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HRS
- PMA / PMN Number
- K090692
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B )(6).
Additional Manufacturer Narrative · 1
VISUAL EXAMINATION SHOWS THE SCREW IS FRACTURED JUST BELOW THE SHANK AT THE PROXIMAL THREADS.
Description of Event or Problem · 1
ALLEGEDLY, THE SCREW WAS BROKEN DURING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 691185 | ORTHOLOC(R) TITANIUM NON-LOCKING SCREW | SMALL JOINT COMPONENT | HRS | WRIGHT MEDICAL TECHNOLOGY, INC. | 1144792 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR |