BEUDAMED
    FDA Adverse Event Death Summary report: N

    CREO MIS

    MDR report key: 18826911 · Received March 4, 2024

    Report

    Report Number
    3004142400-2018-00052
    Event Type
    Death
    Date Received
    March 4, 2024
    Date of Event
    October 11, 2018
    Report Date
    March 4, 2024
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MNH
    UDI-DI
    00889095071146
    PMA / PMN Number
    K124058
    Adverse Event
    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. BASED ON THE REPORTED INFORMATION, IT DOES NOT APPEAR THAT THE CREO MIS DEVICE DIRECTLY CONTRIBUTED TO THE ARREST; HOWEVER, IT MAY HAVE BEEN NECESSARY TO COMPLETE ADDITIONAL SURGICAL STEPS BEFORE THE PATIENT COULD BE REPOSITIONED SUPINE TO RECEIVE RESUSCITATIVE EFFORTS.

    Description of Event or Problem · 0

    THE DESCRIPTION OF THE EVENT STATES THAT HALOING WAS OBSERVED AROUND THE TRANSITION SCREW. HALOING IS AN INDICATION OF SCREW MOVEMENT POST-OPERATIVELY, SUGGESTING THAT FIXATION WAS COMPROMISED AT THIS LEVEL. IT'S POSSIBLE THAT THIS COULD HAVE BEEN CAUSED BY EXCESSIVE STRESS, IMPROPER SCREW SIZING, POOR BONE PURCHASE, OR PSEUDOARTHROSIS AT THAT LEVEL. THE SCREW WAS NOT RETURNED FOR EVALUATION AND THE RADIOGRAPHIC IMAGES WERE NOT AVAILABLE. THE EXACT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709564 CREO MIS CREO MIS MODULAR POLYAXIAL TULIP, 30MM REDUCTION MNH GLOBUS MEDICAL, INC. 00889095071146

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Death