BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT JAVA SYSTEM IMPLANT G

    MDR report key: 2833571 · Received October 29, 2012

    Report

    Report Number
    3003853072-2012-00024
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ZIMMER SPINE
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS EXPECTED TO BE RETURNED BUT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-OPERATIVE SLIPPAGE OF THE CONSTRUCT OCCURRED. AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION WAS AVAILABLE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION THAT IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTINCT JAVA SYSTEM IMPLANT G INSTINCT JAVA SYSTEM IMPLANT G MNI ZIMMER SPINE 046W0AN0000 TBC

    Patients

    Seq Age Sex Outcome Treatment
    1