FDA Adverse Event
Malfunction
Summary report: N
PATHFINDER
MDR report key: 1012301
·
Received March 12, 2008
Report
- Report Number
- 1649384-2008-00095
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- February 15, 2008
- Report Date
- March 12, 2008
- Manufacturer
- ABBOTT SPINE
- Product Code
- HXX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. DEVICE MANUFACTURE DATE IS UNK. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.
Description of Event or Problem · 1
IN 2008, THE SALES REP REPORTED THAT DURING A MINIMAL INVASIVE SURGICAL PROCEDURE (MIS) FOR LUMBAR FUSION, THE DRIVER WOULD NOT HOLD THE CLOSURE TOPS. THE SURGEON USED ANOTHER DRIVER WITHIN THE KIT TO FINISH THE CASE AS INTENDED. THERE WAS NO SURGICAL DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PATHFINDER | CLOSURE TOP/SET SCREW T-HANDLE-QUICK RELEASE-LONG SHAFT | HXX | ABBOTT SPINE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |