BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM

    MDR report key: 2182681 · Received July 5, 2011

    Report

    Report Number
    9617544-2011-00235
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K071373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE SURGEON INSERTED 11 SCREWS AS PART OF A POSTERIOR THORACOLUMBAR FUSION AND FINAL TIGHTENED THE RODS TO THE SCREWS. AFTER FINAL XRAY, HE DECIDED TO TAKE OUT A 7.5MM X 40MM XIA 3 TITANIUM POLYAXIAL SCREW TO REPOSITION IT. AFTER REMOVING THE BLOCKER, HE USED THE STANDARD XIA 3 POLYAXIAL SCREWDRIVER TO REMOVE THE SCREW BUT THE TULIP HEAD BROKE OFF OF THE SCREW UPON REMOVAL. THE BROKEN SCREW WAS REMOVED AND THE SAME SIZE REPLACEMENT SCREW WAS INSERTED."

    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 A90222

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR