BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIF CAGE ASSEMBLY

    MDR report key: 2478537 · Received February 21, 2012

    Report

    Report Number
    3008657535-2012-00015
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Report Date
    February 21, 2012
    Manufacturer
    THEKEN SPINE, LLC
    Product Code
    MAX
    PMA / PMN Number
    K101310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SURGERY THE CAGE SNAPPED INSIDE THE PT WHILE THE SURGEON WAS ENGAGING THE SPIN PLATE. THE REPORTER STATED ¿THERE WAS NO HARM TO THE PT AND THE PARTS WERE RECOVERED; HOWEVER, THIS ADDED 15 MINUTES TO THE TOTAL TIME OF THE SURGERY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALIF CAGE ASSEMBLY APOD PRIME MAX THEKEN SPINE, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1