BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE-C CERVICAL ARTIFICIAL DISC

    MDR report key: 18175055 · Received November 17, 2023

    Report

    Report Number
    MW5148320
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Report Date
    November 15, 2023
    Manufacturer
    GLOBUS MEDICAL INC.
    Product Code
    MJO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE RADIOLOGY TEAM HAVE NOTIFIED US THAT A COMPETITOR COMPANY (GLOBUS) WERE SUPPORTING A SPINE CASE WHEN IT BECAME CLEAR THE SCREWS WERE MISPLACED USING THEIR 2D C ARM. THE SURGEON AND GLOBUS REPS THEN DECIDED TO USE OUR NAVIGATION SYSTEM AND O ARM TO CONTINUE THE CASE. THE SURGEON REQUESTED 6 X 3D SPINS TO COMPLETE THE CASE. THE LOCAL MEDTRONIC SPINE REP IS GOING TO INVESTIGATE FURTHER AND FIND OUT THE EXACT COURSE OF EVENTS. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021724 SECURE-C CERVICAL ARTIFICIAL DISC PROSTHESIS, INTERVERTEBRAL DISC MJO GLOBUS MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown