FDA Adverse Event
Malfunction
Summary report: N
REFLEX-HYBRID SCREW EXTRACTOR INNER SHAFT
MDR report key: 1193153
·
Received October 7, 2008
Report
- Report Number
- 9617544-2008-00114
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 8, 2008
- Report Date
- September 8, 2008
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- LXH
- Removal / Correction Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AVAILABLE ON A SUPPLEMENTAL WITH THE METHOD AND RESULT CODES FOLLOWING EVALUATION BY ENGINEERING.
Description of Event or Problem · 1
IT WAS REPORTED PLATE AND SCREWS WERE IMPLANTED IN 2008. THE TOP SCREWS PULLED OUT OF BONE, AND THE BOTTOM SCREWS WERE ALSO LOOSE...CAUSING REVISION/EXPLANT AS NEEDED. WHILE USING THE SCREW EXTRACTOR TO ATTEMPT TO REMOVE THE FIRST SCREW WHICH WAS LOCKED INTO PLATE, THE STYLAT BROKE. THE SURGEON WAS ABLE TO PULL THE PLATE OUT, LEAVING THE EXTRACTOR INNER SHAFT TIP STILL LODGED IN THE SCREW."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REFLEX-HYBRID SCREW EXTRACTOR INNER SHAFT | INSTRUMENT | LXH | STRYKER SPINE BORDEAUX | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other |