FDA Adverse Event
Malfunction
Summary report: N
REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT
MDR report key: 1993629
·
Received January 6, 2011
Report
- Report Number
- 9617544-2010-00513
- Event Type
- Malfunction
- Date Received
- January 6, 2011
- Date of Event
- December 7, 2010
- Report Date
- December 7, 2010
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT "DURING A REFLEX HYBRID SCREW REMOVAL 2 OF THE SMALL INNER SHAFTS THAT SCREW INTO THE SCREW MALFUNCTIONED. THE FIRST BROKE OFF IN THE SCREW. THE SECOND HAD THE THREADS SO STRIPPED THAT IT WOULDN'T ENGAGE WITH THE SCREW ANY LONGER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT | INSTRUMENT | LXH | STRYKER SPINE BORDEAUX | NA | 09C662 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |