BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPLATE, MEDIUM 6

    MDR report key: 2894144 · Received December 27, 2012

    Report

    Report Number
    1649384-2012-00130
    Event Type
    Injury
    Date Received
    December 27, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ZIMMER SPINE
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE INFIX IMPLANT BECAME UNLOCKED. DURING THE ORIGINAL SURGERY, THE IMPLANT WAS PUT IN AND LOCKED. THE PATIENT WAS TURNED IN ORDER TO PUT IN ADD¿L INSTRUMENTATION. AT THAT TIME, THE SURGEON NOTED THE IMPLANT HAD BECOME ¿UNLOCKED¿. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM THE NEXT DAY AND THE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPLATE, MEDIUM 6 ENPLATE, MEDIUM 6 KWQ ZIMMER SPINE 1801-306 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention