BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVS PL SPACER 7 X 25 X 4 DEG - 8

    MDR report key: 2152197 · Received June 23, 2011

    Report

    Report Number
    9617544-2011-00223
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MAX
    PMA / PMN Number
    K080214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "(B)(6), WAS PACKING THE CAGE WITH AUTOGRAFT AND THE CAGE CRACKED. HE WAS USING A NYLON MALLET AND A FLAT PLASTIC BLOCK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVS PL SPACER 7 X 25 X 4 DEG - 8 IMPLANT MAX STRYKER SPINE BORDEAUX NA 52149

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK