BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM

    MDR report key: 2852140 · Received November 14, 2012

    Report

    Report Number
    9617544-2012-00503
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K071373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED, "DURING FINAL TIGHTENING TULIP HEAD BECAME DISENGAGED FROM SCREW SHAFT ON A 7.5 X 40 SCREW PLACED IN THE SACRUM ON A L4-S1 CONSTRUCT. DR (B)(6) NOTED THAT THERE WAS A REALLY GOOD BITE ON THE SCREW AND THAT IT WAS SEATED IN A WAY THAT THE ROD DID NOT SIT IN THE BOTTOM OF THE SCREW. THE FINAL TIGHTENING DEVICES WERE PLACED ONTO THE SCREW/BLOCKER/ROD TO TIGHTEN AND IT DID NOT FEEL RIGHT. DR (B)(6) TOOK THE CONSTRUCT APART TO CHECK THE SCREW AND THE TULIP PULLED RIGHT OFF. DR (B)(6) DID COMMENT THAT HIS SUSPICION IS THAT BECAUSE OF THE STRENGTH OF THE SCREWS PURCHASE THAT IT WOULD NOT MOVE UPWARD SO THE JOINT, BEING THE WEAKEST PART FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM IMPLANT NKB STRYKER SPINE BORDEAUX NA B06766

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK