FDA Adverse Event
Malfunction
Summary report: N
XIA BLOCKER
MDR report key: 1030545
·
Received April 14, 2008
Report
- Report Number
- 9617544-2008-00033
- Event Type
- Malfunction
- Date Received
- April 14, 2008
- Date of Event
- March 24, 2008
- Report Date
- March 26, 2008
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- KWQ
- PMA / PMN Number
- K060361
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO IS BEING REQUESTED FROM THE SURGEON AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT "XIA BLOCKER CRACKED/SPLIT DURING FINAL TIGHTENING MAKING IT IMPOSSIBLE TO TURN THE BLOCKER IN EITHER DIRECTION. SURGEON WAS ABLE TO REMOVE THE ROD WHICH ALLOWED THE SCREW TO BECOME POLYAXIAL AGAIN. SOLUTION WAS TO USE A DIAMOND BURR TO GET THE BLOCKER OUT OF THE SCREW HEAD."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA BLOCKER | IMPLANT | KWQ | STRYKER SPINE BORDEAUX | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |