BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M6-C INSTRUMENT PREPARATION KIT

    MDR report key: 21297927 · Received January 31, 2025

    Report

    Report Number
    MW5165578
    Event Type
    Injury
    Date Received
    January 31, 2025
    Date of Event
    December 17, 2024
    Report Date
    January 28, 2025
    Manufacturer
    SPINAL KINETICS, INC./ORTHOFIX US LLC
    Product Code
    MJO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE M6-C SPINAL DISC REPLACEMENT IMPLANTED INTO ME COLLAPSED AND BROKE APART. IT CAUSED BONE DESTRUCTION, OSTEOLYSIS, AND I WILL NOT BE THE SAME AGAIN. HAVING LOOKED THIS UP ONLINE THERE ARE 21 PUBLISHED REPORTS ABOUT CATASTROPHIC FAILURE AND SEVERE OSTEOLYSIS. EVEN ON YOUTUBE FAMOUS AMERICAN SURGEONS SPEAK NEGATIVELY ABOUT THIS DEVICE. HOW IS THE FDA ALLOWING ACTIVE PROMOTION OF THIS DEVICE TO CONTINUE. THE ISSUES HAVE BEEN KNOWN ABOUT SINCE AT LEAST 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245126 M6-C INSTRUMENT PREPARATION KIT PROSTHESIS, INTERVERTEBRAL DISC MJO SPINAL KINETICS, INC./ORTHOFIX US LLC M6-C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization