BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIUS GPS

    MDR report key: 18843954 · Received March 6, 2024

    Report

    Report Number
    3004142400-2021-00273
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    October 12, 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. ENGINEERING EVALUATIONS REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. INVESTIGATION OF THE CASE LOGS REVEALED THAT THE ROOT CAUSE WAS USER TECHNIQUE. WHEN LOOKING AT THE PREOPERATIVE MERGE, THERE IS A SHIFT PRESENT IN THE LATERAL MERGE. MERGE SHIFTS CAN CAUSE NAVIGATION INTEGRITY ISSUES AND CAN LEAD TO THE MISPLACEMENT OF SCREWS. THE USER MUST VERIFY THE MERGE BEFORE PROCEEDING TO NAVIGATION. THE TWO SCREWS PLACED USING THE SYSTEM WERE LEFT AS IS. 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

    WE NEEDED TO ABORT THE CASE (FRACTURE TH7, PRE-OP WORKFLOW) WITH EGPS. AFTER PLANNING WITH CREO MIS, C-ARM SHOTS WERE TAKEN IN AP AND LATERAL. SYSTEM MERGED THE SHOTS WITH PREOP SCAN BUT MERGE WAS OFF. WE REPEATED THE REGISTRATION 2 TIMES, AP AND LATERAL SHOTS, WITH THE SAME RESULTS. THE SHIFT WAS MOSTLY VISIBLE AT TH6. WE PLANNED ONE ADDITIONAL LEVEL ABOVE AND BELOW OUR POINT OF INTEREST. THIS TIME THE MERGE LOOKED GOOD. BUT DURING THE FIRST SCREW PLACEMENT(TH6 L) WE SAW THE LITTLE(SOME MM) INACCURACY IN THE DEPTH. THE SURGEON PUT TWO SCREWS (TH6 L AND R) WITH EGPS AND THE LAST TWO SCREWS IN TRADITIONAL WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102226 EXCELSIUS GPS SYSTEM, EXCELSIUS GPS, 120V OLO GLOBUS MEDICAL, INC. 999.893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other