BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KEOS LUMBAR IBFD

    MDR report key: 8356446 · Received February 20, 2019

    Report

    Report Number
    3013921069-2019-00001
    Event Type
    Injury
    Date Received
    February 20, 2019
    Date of Event
    January 10, 2019
    Report Date
    February 12, 2019
    Manufacturer
    KEOS
    Product Code
    MAX
    PMA / PMN Number
    K160631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    IMPLANT BROKE UNDER IMPACTION WITHOUT USING TORSION OR ROTATION. IMPLANT WAS BURRED OUT DUE TO THE LACK OF DISTRACTION IN THE DISC SPACE. SMALL PORTION OF THE TIP REMAINED AND A SIMILAR IMPLANT OF THE SAME SIZE WAS THEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148225 KEOS LUMBAR IBFD INTERVERTEBRAL FUSION DEVICE MAX KEOS KPS2-231007 1848F06

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention