BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVS UNILIF SPACER 9 X 30 X 4 DEG - 11MM

    MDR report key: 1760640 · Received July 9, 2010

    Report

    Report Number
    9617544-2010-00274
    Event Type
    Malfunction
    Date Received
    July 9, 2010
    Date of Event
    May 25, 2010
    Report Date
    May 25, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MAX
    PMA / PMN Number
    K090816
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 "SURGEON TRIALED AN 8 IMPLANT AND IMPLANTED A 9 UNILIF CAGE. SURGEON WAS AWARE OF TRIALING AND IMPLANTING THE SAME SIZE BUT DECIDED TO GO WITH THE BIGGER SIZE. IMPLANT WAS HEAVILY IMPACTED INTO DISC SPACE WITH FORCE AND BROKE UPON INSERTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVS UNILIF SPACER 9 X 30 X 4 DEG - 11MM IMPLANT MAX STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR