BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVS UNILIF SPACER 9 X 33 X 4DEG - 11MM

    MDR report key: 2081143 · Received April 14, 2011

    Report

    Report Number
    9617544-2011-00133
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MAX
    PMA / PMN Number
    K090816
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, 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, "DR (B)(6) WAS IMPACTING A UNILIF SPACER INTO THE L2-3 DISC SPACE, AND UPON HIS THIRD IMPACTION, THE UNILIF SPACER BROKE IN HALF. HALF OF THE IMPLANT WAS STILL ON THE INSERTER AND HALF WAS IN THE WOUND. HE PULLED THE PIECE OUT OF THE DISC SPACE AND WE INSERTED A NEW SPACER OF THE SAME SIZE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVS UNILIF SPACER 9 X 33 X 4DEG - 11MM IMPLANT MAX STRYKER SPINE BORDEAUX NA TE3

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR