FDA Adverse Event
Injury
Summary report: N
XIA 3 TITANIUM BLOCKER
MDR report key: 2922249
·
Received January 11, 2013
Report
- Report Number
- 9617544-2013-90022
- Event Type
- Injury
- Date Received
- January 11, 2013
- Date of Event
- December 13, 2012
- Report Date
- December 14, 2012
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- NKB
- PMA / PMN Number
- 48230000
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE THIS WILL BE REPORTED AS SUPPLEMENTAL.
Description of Event or Problem · 1
ON (B)(6) 2013 REVISION OF XIA3 WAS PERFORMED BECAUSE THE BLOCKER CAME OFF FROM THE SCREW HEAD. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2011, TRIO WAS USED TO THE POSTERIOR SPINAL FUSION. AFTER THAT ON (B)(6) 2012 BECAUSE OF THE ADJACENT SEGMENTAL DISEASES, THE REVISION OF EXTENSION WITH XIA3 WAS PERFORMED. THEN IT WAS CONFIRMED THAT THE BLOCKER OF XIA3 WAS PERFORMED. THEN IT WAS CONFIRMED THAT THE BLOCKER OF XIA3 CAME OFF FROM THE SCREW HEAD. ON (B)(6) 2012 SCREWS OF TRIO AND 2 ANGLED OPEN CONNECTOR OF XIA3 WERE EXTRACTED AND 2 CLOSED PARALLEL CONNECTOR WERE USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18729 | XIA 3 TITANIUM BLOCKER | IMPLANT | NKB | STRYKER SPINE BORDEAUX | NA | MW3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| R |