BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALEUTIAN

    MDR report key: 3841621 · Received May 30, 2014

    Report

    Report Number
    3004774118-2014-00020
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 30, 2014
    Manufacturer
    K2M, INC.
    Product Code
    MAX
    PMA / PMN Number
    K090707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS SUCCESSFULLY REVISED HOWEVER, THE PART WAS INADVERTENTLY DISCARDED AND IS UNAVAILABLE FOR EVALUATION. A GENERAL REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS FOR THE PART WAS PERFORMED AND NO DISCREPANCIES WERE FOUND. NO SPECIFIC ROOT CAUSE HAS BEEN DETERMINED HOWEVER, WE WILL CONTINUE TO MONITOR INCIDENTS OF THIS NATURE. DEVICE DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    ALEUTIAN LATERAL CAGE BACKED OUT APPROXIMATELY TWO MONTHS POST-OPERATIVELY. THE PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318703 ALEUTIAN INTERBODY MAX K2M, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention