BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURE C

    MDR report key: 11174556 · Received January 14, 2021

    Report

    Report Number
    3004142400-2021-00008
    Event Type
    Injury
    Date Received
    January 14, 2021
    Date of Event
    October 13, 2020
    Report Date
    December 18, 2020
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    QLQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR ANY IMAGING WAS AVAILABLE FOR EVALUATION. IT WAS REPORTED THAT AFTER USING THE BROACHING CHISEL, THE SURGEON THEN ENCOUNTERED DIFFICULTY WHILE ADVANCING THE KEEL CHISEL OVER THE TRIAL AND USED MORE FORCE TO ADVANCE THE CHISEL OVER THE TRIAL TO ITS INTENDED POSITION, WHICH CAUSED THEM TO ADVANCE TOO FAR. NO FLUOROSCOPIC GUIDANCE WAS USED DURING THIS STEP AS RECOMMENDED IN THE SURGICAL TECHNIQUE. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AND NO PATIENT IMAGING WAS PROVIDED. THE 6MM AND 7MM TRIALS FROM THE SET WERE EVALUATED AND FUNCTIONED AS INTENDED. THE LACK OF FLUOROSCOPIC GUIDANCE WHILE ADVANCING THE CHISEL MAY HAVE CONTRIBUTED TO THIS EVENT; HOWEVER, THE EXACT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SECURE C CASE, THE TRIAL AND KEEL CHISEL WERE ADVANCED TOO FAR IN THE DISC SPACE DURING PREPARATION. FOLLOWING REMOVAL OF THE TRIAL, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SERIOUS ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71429 SECURE C SECURE C TRIAL QLQ GLOBUS MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1