BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIUS GPS

    MDR report key: 18843254 · Received March 5, 2024

    Report

    Report Number
    3004142400-2021-00250
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    March 29, 2021
    Report Date
    March 5, 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
    OTHER

    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. INVESTIGATION OF THE CASE LOGS FOUND THAT THE ROOT CAUSE WAS USER TECHNIQUE. THERE WAS NO SURVEILLANCE MARKER ACTIVATED DURING THE CASE, MEANING SHIFTS IN THE DYNAMIC REFERENCE BASE (DRB) WOULD NOT BE DETECTED. INVESTIGATION OF THE MERGE SHOWED THAT THERE IS A TRACKING ERROR PRESENT IN THE FLUOROSCOPY IMAGES USED FOR THE LEVEL OF L5. THESE TRACKING ERRORS CAN BE CAUSED BY A SHIFT IN THE DRB DURING WHEN FLUOROSCOPY IMAGES ARE BEING CAPTURED, OR BY THE USER HITTING THE REFRESH BUTTON TO BRING A NEW IMAGE TO THE SYSTEM. THE REFRESH BUTTON CAUSES A TRACKING ERROR IF THE C-ARM IS NOT IN THE SAME POSITION AS WHEN THE X-RAY WAS EMITTED. TRACKING ERRORS WILL CAUSE THE SHIFTS TO BE PRESENT IN THE MERGE. THE USER MANUAL INSTRUCTS THE USER ON HOW TO PERFORM LANDMARK CHECKS AND TO RE-IMAGE THE PATIENT IF NECESSARY IN ORDER TO ENSURE NAVIGATION INTEGRITY. THE USER MUST VERIFY THE MERGE BEFORE PROCEEDING TO NAVIGATE. THE REMAINDER OF THE CASE WAS SUCCESSFULLY COMPLETED USING THE SYSTEM AND THERE WAS NO ADVERSE EFFECT TO THE PATIENT. THE CAUSE OF THE REPORTED ISSUE WAS TRACED TO USER TECHNIQUE.

    Description of Event or Problem · 0

    ONE OF THE SCREWS "MISSED" ITS TRAJECTORY. THE PATIENT WAS UNAFFECTED, BUT WANTED TO SEND THIS IN UNDER AN EEF TO HELP DISCERN WHAT HAPPENED. THE MERGE WAS SUCCESSFUL FOR A PRE-OP WORKFLOW AND ALL ACTIVITY TO IMPLANT THE SCREWS WERE ON PAR FOR ACCURATE NAVIGATION AND OUTCOME. BUT APPARENTLY WHEN VERIFYING WITH FLOURO, ONE OF THE SCREWS WAS OUT OF PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1656533 EXCELSIUS GPS SYSTEM, EXCELSIUS GPS, 120V OLO GLOBUS MEDICAL, INC. 999.893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other