BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELSIUS

    MDR report key: 18888339 · Received March 12, 2024

    Report

    Report Number
    3004142400-2024-00048
    Event Type
    Injury
    Date Received
    March 12, 2024
    Date of Event
    February 12, 2024
    Report Date
    March 12, 2024
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    OLO
    PMA / PMN Number
    K171651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. THE PURPOSE OF THIS INVESTIGATION IS TO EVALUATE THE RISK ASSOCIATED WITH THE IDENTIFIED FAILURE MODE OF "MISPLACED TOOLS OR IMPLANTS" FOR EXCELSIUSGPS. INVESTIGATION OF THE CASE LOGS SHOWED THAT THE ROOT CAUSE OF THE MISPLACED IMPLANTS IS DUE TO A COMBINATION OF SKIVING, PATIENT MOVEMENT RELATIVE TO THE DRB AND TRACKING ERRORS IN THE FLUOROSCOPIC IMAGES. FOR SKIVING, THE USER REPORTED THAT THEY SKIVED DUE TO SMALL AND SCLEROTIC PEDICLES. ADDITIONALLY, INVESTIGATION OF THE CASE LOGS SHOWED THAT THE SOFTWARE DETECTED EXCESSIVE FORCES ON THE LOAD CELL DURING BONE WORK. THIS IS THE RESULT OF SKIVING FORCES DETECTED WHILE A TOOL IS INSERTED INTO THE END EFFECTOR. THE SOFTWARE CORRECTLY DETECTED THIS FORCE AND ALERTED THE USER. MISPLACED SCREWS DUE TO SKIVING IS BEING FURTHER INVESTIGATED IN RELATIONSHIP TO CAPA-23-0052. FOR PATIENT MOVEMENT RELATIVE TO DRB, IT WAS REPORTED THAT THE SURGEON CONTINUED TO DISSECT AND INCISE FURTHER FOLLOWING PATIENT REGISTRATION. THIS CAN LEAD TO MOVEMENT OF THE PATIENT'S ANATOMY RELATIVE TO THE DRB, RESULTING IN MISPLACED IMPLANTS. FURTHERMORE, REVIEW OF THE FLUOROSCOPIC IMAGES REVEALED THAT ASSIGNED IMAGES CONTAINED TRACKING ERRORS. A TRACKING ERROR CAN OCCUR IF THE C-ARM MOVES WITH RESPECT TO THE PATIENT BETWEEN X-RAY EMISSION AND WHEN THE IMAGE IS RECEIVED BY THE EXCELSIUSGPS SOFTWARE. TRACKING ERRORS CAN LEAD TO PREOPERATIVE MERGE SHIFTS AND NAVIGATIONAL INTEGRITY ISSUES. THE CAUSE OF THE REPORTED ISSUE WAS TRACED TO USER TECHNIQUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCREW USING THE EXCELSIUS GPS SYSTEM WAS MISPLACED INTRA-OPERATIVELY CAUSING A CSF (CEREBRAL SPINAL FLUID) LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721176 EXCELSIUS SYSTEM, EXCELSIUS GPS, 120V OLO GLOBUS MEDICAL, INC. 6143.1001 GPS-0208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other