BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA BLOCKER

    MDR report key: 1881949 · Received October 11, 2010

    Report

    Report Number
    9617544-2010-00409
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K060361
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 ¿THREADS ON THE BLOCKER STARTED TO STRIP UPON INSERTION OF THE BLOCKER. IMPLANTS WERE NOT RETURNED BACK TO ME UNTIL A FEW DAYS AFTER SURGERY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA BLOCKER IMPLANT NKB STRYKER SPINE BORDEAUX NA VXR

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK