BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARS 3VL

    MDR report key: 18924828 · Received March 18, 2024

    Report

    Report Number
    3004142400-2024-00051
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    February 6, 2024
    Report Date
    March 14, 2024
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. THE BLADE WAS INSPECTED AND WAS FOUND TO HAVE FRACTURED AT THE PROXIMAL INSIDE EDGE. THE HARD-COAT ANODIZATION IS REMOVED AT THE LOCATION OF THE FRACTURE AS WELL ON THE ANTERIOR EDGE DOWN THE LENGTH OF THE BLADE. THIS PART WAS USED IN A L2-L5 LLIF PROCEDURE IN JAPAN USING RISE-L INTERBODY SPACERS. NO COMPLICATIONS OR HARM TO THE PATIENT WAS REPORTED. IT IS UNKNOWN IF ANY ADDITIONAL FRAGMENTS WERE LEFT IN THE PATIENT OR IF REVISION SURGERY IS PLANNED. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGERY THAT A PIECE OF THE INSTRUMENT WAS BROKEN AND MAY BE LEFT IN THE PATIENT POST OPERATIVELY. THIS EVENT OCCURRED IN JAPAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2376039 MARS 3VL BLADE, IBP, LEFT, 120MM GAD GLOBUS MEDICAL, INC. 6133.3121 FCX094FB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other