FDA Adverse Event
Malfunction
Summary report: N
(END) SCREW EXTENDER SLEEVE
MDR report key: 1190757
·
Received October 6, 2008
Report
- Report Number
- 1649384-2008-00515
- Event Type
- Malfunction
- Date Received
- October 6, 2008
- Date of Event
- September 8, 2008
- Report Date
- October 6, 2008
- Manufacturer
- ABBOTT SPINE
- Product Code
- KWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. EVALUATION IS PENDING.
Description of Event or Problem · 1
THE SALES REPRESENTATIVE REPORTED THAT DURING AN L-5 GRADE 3 SPONDYLOLISTHESIS SURGERY IN (B) (6) 2008, THE END SCREW EXTENDER SLEEVE CAME OFF OF THE SCREW. THERE WAS MINIMAL SURGICAL DELAY AND NO HARM TO THE PT. THE MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | (END) SCREW EXTENDER SLEEVE | PATHFINDER | KWP | ABBOTT SPINE | 48MB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |