FDA Adverse Event
Malfunction
Summary report: N
SCREW
MDR report key: 2192725
·
Received July 14, 2011
Report
- Report Number
- 2520274-2011-00508
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Date of Event
- April 16, 2009
- Report Date
- July 1, 2009
- Manufacturer
- SYNTHES (USA)
- Product Code
- NQP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
NFLEX WAS IMPLANTED AT L2-S1. SURGEON REPORTED RADIOGRAPHIC EVIDENCE OF SCREW LOOSENING AT ONE YEAR FOLLOW UP. IT IS UNK IF THE DEVICE WAS EXPLANTED. THIS IS THE THIRD OF THREE REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREW | SCREW | NQP | SYNTHES (USA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | SCREWS| RODS |