BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OIC PEEK SIZE 9 MM - 4DEG

    MDR report key: 2676102 · Received July 26, 2012

    Report

    Report Number
    9617544-2012-00311
    Event Type
    Malfunction
    Date Received
    July 26, 2012
    Date of Event
    July 2, 2012
    Report Date
    July 2, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MAX
    PMA / PMN Number
    K101051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE, THIS WILL BE REPORTED AS SUPPLEMENTAL. METHOD, RESULT AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVAL.

    Description of Event or Problem · 1

    DURING OIC PEEK SURGERY, THE SURGEON TRIED TO INSERT THE OIC PEEK INTO THE VERTEBRAL DISC. WHEN THE SURGEON ASSEMBLED INSERTER WITH OIC PEEK, AND INSERTED OIC PEEK TO THE VERTEBRAL DISC, OIC PEEK BROKE. THE SURGEON REMOVED BROKEN OIC PEEK. AND THE SURGEON CHANGED THE BROKEN OIC PEEK TO ANOTHER SIZE OIC PEEK. THE SURGEON REQUESTED THE INVESTIGATION OF THE BROKEN OIC PEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OIC PEEK SIZE 9 MM - 4DEG IMPLANT MAX STRYKER SPINE BORDEAUX NA 63592

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK