BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELSIUS GPS

    MDR report key: 21264883 · Received January 29, 2025

    Report

    Report Number
    3004142400-2024-00367
    Event Type
    Injury
    Date Received
    January 29, 2025
    Date of Event
    July 26, 2022
    Report Date
    January 29, 2025
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    OLO
    UDI-DI
    00889095481297
    PMA / PMN Number
    K171651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS BEING REPORTED FOR A PROBLEM FOUND EARLIER. INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. ENGINEERING EVALUATION DID NOT FIND A SYSTEM MALFUNCTION. UPON INVESTIGATION, IT WAS FOUND THAT THE CT WAS OUT OF SPEC. CT VALUES ARE EXPECTED TO USE CALIBRATED HOUNSFIELD UNITS. IT WAS FOUND THAT THE CT USED IN THIS CASE HAD INCORRECT VALUES AROUND THE BORDER OF THE IMAGE WHERE THERE WAS AIR. THESE LOW INTENSITY VOXELS WERE VISIBLE IN THE DRR RENDERING. EVEN WITH THESE VOXELS, A FLUORO-CT MERGE WAS ABLE TO BE COMPLETED. ULTIMATELY, THE USER ABORTED THE ROBOT IN THIS CASE AND THERE WAS NO REPORTED ADVERSE EFFECT TO THE PATIENT. THE OBSERVED OVERALL RISK LEVEL IS LOW WHICH MATCHES THE OBSERVED ANTICIPATED RISK LEVEL; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED AND THERE IS NO FURTHER INVESTIGATION REQUIRED. THE CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE.

    Description of Event or Problem · 0

    HAD A VERY DIFFICULT TIME GETTING A MERGE. THE DRR WAS LESS THAN SUFFICIENT AS FAR AS QUALITY/BEING ABLE TO MERGE WITH OUR FLUORO SHOTS. OUR FLUORO SHOTS I THOUGHT WERE GREAT, BUT ULTIMATELY HAD NO EXPLANATION FOR NOT BEING ABLE TO GET A MERGE. WE WENT BACK ADJUSTED THE WINDOWING ON THE CT. THAT DIDN'T HELP. "DEEP SEARCH" AND "AUTO MERGE" WERE ATTEMPTED SEVERAL TIMES AFTER MOVING THE DRR INTO WHAT I FELT/COULD MAKE OUT TO BE THE MATCHING ANATOMY OF THE FLUORO SHOTS. THERE WAS SOME WEIRD BOX IN THE DRR THAT I COULD NOT EXPLAIN EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047329 EXCELSIUS GPS SYSTEM, EXCELSIUS GPS, 120V OLO GLOBUS MEDICAL, INC. 6143.1001 GPS-0300 00889095481297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other