BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LORDOTIC CALIX PC CAGE

    MDR report key: 5035592 · Received August 21, 2015

    Report

    Report Number
    MW5055770
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 29, 2015
    Manufacturer
    X-SPINE SYSTEMS INC.
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    LORDOTIC CALIX PC CAGE BROKE INTO 2 PIECES ON IMPLANTATION. BOTH PIECES RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555629 LORDOTIC CALIX PC CAGE LORDOTIC CALIX PC CAGE MQP X-SPINE SYSTEMS INC. X034-0391PC

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR