BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM MULTIAXIAL CROSSLINK 43MM 54MM

    MDR report key: 2152297 · Received June 23, 2011

    Report

    Report Number
    9617544-2011-00220
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 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
    FL, 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 ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "UPON TIGHTENING CENTER NUT OF CROSS LINK THE SET SCREW POPPED OUT INTO THE WOUND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 TITANIUM MULTIAXIAL CROSSLINK 43MM 54MM IMPLANT NKB STRYKER SPINE BORDEAUX NA 10G982

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR