BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA BLOCKER

    MDR report key: 1760624 · Received July 9, 2010

    Report

    Report Number
    9617544-2010-00261
    Event Type
    Malfunction
    Date Received
    July 9, 2010
    Date of Event
    December 22, 2009
    Report Date
    May 24, 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
    IA, 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 WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE PATIENT CAME IN FOR THE MONTHLY CHECK UP AND ONE OF OUR MANTIS SCREWS WERE BROKE. ALSO, ON THE OTHER SIDE, ONE SET SCREW HAD POPPED OFF. SURGERY IS 5-6 MONTHS OLD."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK