BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIUS GPS

    MDR report key: 18843693 · Received March 6, 2024

    Report

    Report Number
    3004142400-2021-00268
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    July 19, 2021
    Report Date
    March 6, 2024
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    OLO
    PMA / PMN Number
    K171651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING RESUBMITTED FOR AN INCIDENT THAT OCCURRED EARLIER. INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. OUR ENGINEERING EVALUATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. OUR INVESTIGATION OF THE CASE LOGS REVEALED THAT THE ROOT CAUSE WAS USER TECHNIQUE. THE SOFTWARE DETECTED A DYNAMIC REFERENCE BASE (DRB) SHIFT. THE USER WAS PRESENTED WITH A WARNING SAYING "SURVEILLANCE SHIFT. POSSIBLE SHIFT OF THE DRB DETECTED BY SURVEILLANCE MARKER. TRAJECTORY MOTION DISABLED. PERFORM AN ANATOMICAL LANDMARK CHECK AND RESET SURVEILLANCE IF APPLICABLE". THE USER THEN PROCEEDED TO NAVIGATION. THE CAUSE OF THE REPORTED ISSUE WAS TRACED TO USER TECHNIQUE.

    Description of Event or Problem · 0

    THIS WAS THE SURGEON'S FIRST CASE. HE PLANNED ON DOING CORTICAL TRAJECTORY SCREWS AT L3 AND L4 USING CREO MIS. THIS PATIENT HAD SIGNIFICANT CORONAL DEFORMITY AND ROTATION. THE LEVEL WE WERE WORKING ON WAS ALMOST BONE-ON-BONE. THEY ALSO HAD OVERGROWN FACETS AND LARGE SPINOUS PROCESSES THAT THE SURGEON DID NOT WANT TO TAKE OFF. ALL OF THESE FACTORS MADE IT VERY DIFFICULT TO PLAN TRUE CORTICAL TRAJECTORIES. WE THOUGHT THE REGISTRATION WAS SUCCESSFULLY OBTAINED, AND THE LANDMARK CHECK LOOKED ACCEPTABLE DESPITE THE PATIENT HAVING AROUND A 40 BMI. HOWEVER, ALL SCREWS MISSED LOW TO THE PLAN, SO SOMETHING CAUSED INACCURACIES POST-REGISTRATION OR DURING REGISTRATION. THE WAY THE SURGEON HAD THE DRB ORIENTED PUT THE WING NUT VERY CLOSE TO THE ICT CLAMP. HE COULD HAVE EASILY BUMPED IT WHEN TAKING THE ICT OFF IF HE WAS NOT PAYING ATTENTION. WE RECEIVED A SURVEILLANCE SHIFT MESSAGE, SO I HAD HIM DRAG THE CHICKEN FOOT OVER WHERE HE THOUGHT A SPINOUS PROCESS WAS. IN HINDSIGHT, I SHOULD HAVE HAD HIM EITHER CHECK THE DRB TO MAKE SURE IT DIDN'T CLICK UP OR DOWN, CHECK TO MAKE SURE THE QUATTRO SPIKE WAS STILL SECURE, OR EXPOSE BEFORE THE SPIN SO HE COULD DO A TRUE LANDMARK CHECK. UPON TAKING CONFIRMATION SHOTS, ALL SCREWS LOOKED LIKE THEY WERE ACCORDING TO PLAN MEDIALLY AND LATERALLY, HOWEVER THEY ALL WERE ABOUT 3 MM LOWER THAN THE PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670109 EXCELSIUS GPS SYSTEM, EXCELSIUS GPS, 120V OLO GLOBUS MEDICAL, INC. 999.893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other