BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELSIUS GPS

    MDR report key: 23360335 · Received October 22, 2025

    Report

    Report Number
    3004142400-2025-00257
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    June 3, 2025
    Report Date
    November 20, 2025
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    OLO
    UDI-DI
    00889095481297
    PMA / PMN Number
    K171651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED IN THE INITIAL EVENT EVALUATION FORM (EEF) THAT THIS PROCEDURE WAS ABORTED. HOWEVER, ON (B)(6) 2025, IT WAS CLARIFIED THAT THE USAGE OF EXCELSIUSGPS WAS ABORTED DUE TO A MISPLACED IMPLANT. THE FAILURE MODE FOR THE MISPLACED IMPLANT WAS INVESTIGATED UNDER 3004142400-2025-00140. THROUGH ADDITIONAL FOLLOW-UP IT WAS DETERMINED THIS EEF WAS INCORRECTLY MARKED AS AN ABORTED PROCEDURE. AS A RESULT, THIS FAILURE THAT LED TO THIS COMPLAINT BEING CLASSIFIED AS A REPORTABLE EVENT DOES NOT MEET THE REPORTABILITY CRITERIA AS PER THE MDR REPORTABILITY CHECKLIST. THE USER REPORTED DIFFICULTY WITH THE VERIFICATION OF THE EXCELSIUS UNIVERSAL ARRAYS. THE VERIFICATION OF INSTRUMENTS CAN BE AFFECTED BY NON-DEVICE RELATED FACTORS SUCH AS PASSIVE SPHERES, VERIFICATION TECHNIQUE, OR LIGHTING, DAMAGE TO THE ARRAY OR DAMAGE TO THE INSTRUMENT. TROUBLESHOOTING TECHNIQUES THAT CAN BE USED WHEN BEING PRESENTED WITH INSTRUMENT VERIFICATION ISSUES INCLUDE: ADJUSTING OR REPLACING THE ARRAY SPHERES, VERIFYING INSTRUMENTS OFF THE END EFFECTOR, SWITCHING OUT THE INSTRUMENT OR ARRAY, OR REDUCING REFLECTION CAUSED BY OPERATING ROOM LIGHTS. AS PART OF THE INVESTIGATION, BOTH UNIVERSAL ARRAYS WERE RETURNED AND SWAPPED. ULTIMATELY, THE CASE WAS COMPLETED USING A COMPETING SYSTEM WITH NO ADVERSE EFFECT TO THE PATIENT REPORTED. THE SEVERITY OBSERVED MATCHES THE ANTICIPATED COMPLAINT SEVERITY. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH MATCHES THE OBSERVED ANTICIPATED RISK LEVEL; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED. THE FOLLOWING SECTIONS WERE UPDATED FOR THIS SUPPLEMENTAL REPORT: B4, D4, G6, H2, H3, H6, H10.

    Additional Manufacturer Narrative · 0

    THE CASE LOGS HAVE NOT BEEN REVIEWED FOR EVALUATION. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RELINE MAS REDUCTION SCREWS WERE UTILIZED WITH THE ROBOT FOR THIS CASE. BLACK EXCELSIUS ARRAY WITH AN ADAPTER WAS UTILIZED. TWO EXCELSIUS ARRAYS WERE SET UP WITH MAS REDUCTION DRIVERS AND VERIFICATION OF THESE ARRAYS WAS CHALLENGING. THE CAMERA WAS HAVING A HARD TIME SEEING THESE ARRAYS. SPHERES WERE MANIPULATED MULTIPLE TIMES AND BOTH DRIVER ARRAYS WERE TRIED. ONCE THE CAMERA WAS ABLE TO SEE THE ARRAYS, IT TOOK MULTIPLE VERIFICATION ATTEMPTS AND MANIPULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RELINE MAS REDUCTION SCREWS WERE UTILIZED WITH THE ROBOT FOR THIS CASE. BLACK EXCELSIUS ARRAY WITH AN ADAPTER WAS UTILIZED. TWO EXCELSIUS ARRAYS WERE SET UP WITH MAS REDUCTION DRIVERS AND VERIFICATION OF THESE ARRAYS WAS CHALLENGING. THE CAMERA WAS HAVING A HARD TIME SEEING THESE ARRAYS. SPHERES WERE MANIPULATED MULTIPLE TIMES AND BOTH DRIVER ARRAYS WERE TRIED. ONCE THE CAMERA WAS ABLE TO SEE THE ARRAYS, IT TOOK MULTIPLE VERIFICATION ATTEMPTS AND MANIPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228552 EXCELSIUS GPS ROBOT, SURGICAL, NAVIGATION UNIT OLO GLOBUS MEDICAL, INC. 6143.1001 GPS-0572 00889095481297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other