FDA Adverse Event
Malfunction
Summary report: N
SET SCREW STAR DRIVER - SHORT
MDR report key: 2853197
·
Received July 10, 2008
Report
- Report Number
- 1649384-2008-00371
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Date of Event
- June 11, 2008
- Report Date
- July 10, 2008
- Manufacturer
- ABBOTT SPINE
- Product Code
- HXX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PATIENT INVOLVEMENT. PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. REQUESTS HAVE BEEN MADE TO RETURN THE PRODUCT. DEVICE MANUFACTURE DATE IS UNKNOWN. EVALUATION IS PENDING UPON RETURN OF THE PRODUCT.
Description of Event or Problem · 1
ON (B)(6) 2008, THE SALES REPRESENTATIVE REPORTED THAT DURING A KIT INSPECTION THE END OF THE INSTRUMENT WAS SLIGHTLY TWISTED AND UPON TESTING FOUND THAT IT WOULD NOT ENGAGE A SCREW. THE PRODUCT WAS REPLACED WITH THE SAME PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. THE MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SET SCREW STAR DRIVER - SHORT | NEXLINK | HXX | ABBOTT SPINE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |