BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIUS GPS

    MDR report key: 18843129 · Received March 5, 2024

    Report

    Report Number
    3004142400-2020-00191
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    October 7, 2020
    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
    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 EVALUATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. OUR INVESTIGATION OF THE CASE LOGS FOUND THAT THE SYSTEM OPERATED AS INTENDED. THE ROOT CAUSE WAS USER TECHNIQUE. THE INVESTIGATION FOUND THAT THE THERE WERE MULTIPLE SHIFTS IN THE POSITION OF THE PATIENT REFERENCE ARRAY DURING THE SURGERY, SPECIFICALLY BEFORE THE USER STARTED WORKING ON THE L5 LEVEL. THIS SHIFT EXPLAINS WHY THE SCREWS AT THIS LEVEL WERE MISSED. AFTER THE SHIFT, THE USER ZEROED THE POSITION OF THE SURVEILLANCE MARKER TO SUPPRESS THE WARNING AND CONTINUED WITH THE SURGERY. THE REMAINDER OF THE CASE WAS SUCCESSFULLY COMPLETED USING TRADITIONAL MEANS AND THERE WAS NO ADVERSE IMPACT TO THE PATIENT. THE CAUSE OF THE REPORTED ISSUE WAS TRACED TO USER TECHNIQUE.

    Description of Event or Problem · 0

    THE SURGEON HAD A MISPLACED L5 SCREW ON THE LEFT. MERGE SCORES WERE A 6 AND SURGEON DID NOT NOTE ANY MOVEMENT DURING REGISTRATION. THE SURGEON MADE A COMMENT ABOUT THE BONE BEING SCLEROTIC AND WE ENDED UP TAPPING ONE OF THE SCREWS (NOT THIS ONE). UPON POST SCREW PLACEMENT XRAYS WE COULD SEE THE MISPLACED SCREW. WHEN LINING IT UP WITH OUR PRE-OP PLAN IT CLEARLY DID NOT LINE UP WITH THIS LEVEL. THE SCREW INITIALLY STIMMED AT 7MA, AFTER FREE HANDING THE SCREW INTO THE PLANNED TRAJECTORY IT RESTIMMED AT 12MA AND SURGERY PROCEEDED. ADDITIONALLY AT THIS LEVEL, L5, WE HAD TO POP THE END EFFECTOR OFF ON BOTH LEFT AND RIGHT SIDE (EVEN WITH THE SURGEON LEAVING THE SCREWS PROUD). ISSUES USING THE HIGH SPEED DRILL WITH THE RIGHT L4 (FIRST SCREW PLACED) DUE TO A WARPED HIGH SPEED SLEEVE. WE REPLACED IT AFTER THIS SCREW AND FILLED OUT A SEPARATE EEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629697 EXCELSIUS GPS SYSTEM, EXCELSIUS GPS, 120V OLO GLOBUS MEDICAL, INC. 999.893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other