BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT JAVA SYSTEM GENERIC IMPLANT

    MDR report key: 2903675 · Received January 4, 2013

    Report

    Report Number
    3003853072-2013-00032
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    December 6, 2012
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-OPERATIVELY ROD MICROMOTION WAS FOUND IN A 1 LEVEL CONSTRUCT WITH MONO-AXIAL SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4099 INSTINCT JAVA SYSTEM GENERIC IMPLANT INSTINCT JAVA SYSTEM GENERIC IMPLANT NKB ZIMMER SPINE INSTINCT JAVA SYSTEM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1