BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPLEX IMPLANT

    MDR report key: 930654 · Received October 17, 2007

    Report

    Report Number
    2242816-2007-00049
    Event Type
    Malfunction
    Date Received
    October 17, 2007
    Date of Event
    October 3, 2007
    Report Date
    October 4, 2007
    Manufacturer
    EBI
    Product Code
    JDK
    PMA / PMN Number
    K023908
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGICAL PROCEDURE: C3-7 ACDF. THE LAST 4 OF BIOPLEX C IMPLANTS WERE BEING PLACED AT C6-7. THE IMPLANT FRACTURED AT EACH CORNER DURING INITIAL, LIGHT IMPACTING OF THE IMPLANT INTO THE DISC SPACE. PATIENT OUTCOME: OK. FRACTURED IMPLANT WAS NOT USED. AN ADDITIONAL IMPLANT WAS AVAILABLE AND WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPLEX IMPLANT JDK EBI 591050

    Patients

    Seq Age Sex Outcome Treatment
    1 YR