FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL DRIVER
MDR report key: 1308557
·
Received January 8, 2009
Report
- Report Number
- 1649384-2009-00005
- Event Type
- Malfunction
- Date Received
- January 8, 2009
- Date of Event
- December 18, 2008
- Report Date
- January 8, 2009
- Manufacturer
- ABBOTT SPINE, INC.
- Product Code
- HXX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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. REQUESTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.
Description of Event or Problem · 1
ON (B) (6) 2008, THE DISTRIBUTOR REPORTED THAT DURING SURGERY, THE REVISION TOOL BENT. ADDITIONAL INFO RECEIVED VIA EMAIL FROM DISTRIBUTOR ON 06 JAN 2009, THE DISTRIBUTOR REPORTED THAT THE REVISION SURGERY WAS FOR REMOVAL OF HARDWARE AND TO INSTRUMENT OTHER LEVELS. THIS MALFUNCTION HAS BEEN REPORTED FOR AN ADVERSE EVENT IN THE PAST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL DRIVER | INCOMPASS | HXX | ABBOTT SPINE, INC. | 25YF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |