BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZAVATION

    MDR report key: 5085525 · Received September 17, 2015

    Report

    Report Number
    3008583793-2015-00001
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Manufacturer
    ZAVATION
    Product Code
    MAX
    PMA / PMN Number
    K112664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT DATE 08/07/2015. EVENT TYPE MALFUNCTION. EVENT DESCRIPTION DURING SURGERY, A CIF CAGE WAS IMPLANTED BY SURGEON. WHEN X-RAY WAS TAKEN NO TANTALUM MARKERS WERE VISIBLE TO CONFIRM THE POSITION OF THE IMPLANT. SURGEON REMOVED 'BAD' CIF CAGE AND IMPLANTED A SECOND CIF CAGE WITH NO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616921 ZAVATION CIF CAGE MAX ZAVATION 20-0605 1006ZV

    Patients

    Seq Age Sex Outcome Treatment
    1