BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 30 MM

    MDR report key: 2934361 · Received January 11, 2013

    Report

    Report Number
    9617544-2013-90025
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K071373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE, THIS WILL BE REPORTED AS SUPPLEMENTAL. METHOD RESULT AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "XIA SCREW HEAD DETACHED FROM SCREW SHAFT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19320 XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 30 MM IMPLANT NKB STRYKER SPINE BORDEAUX NA A85061

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR