BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M6-C

    MDR report key: 21415301 · Received February 19, 2025

    Report

    Report Number
    MW5166507
    Event Type
    Injury
    Date Received
    February 19, 2025
    Date of Event
    December 2, 2024
    Report Date
    February 14, 2025
    Manufacturer
    ORTHOFIX US LLC
    Product Code
    MJO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CORE COLLAPSE AND SEVERE OSTEOLYSIS OF THE M6-C DISC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269140 M6-C PROSTHESIS, INTERVERTEBRAL DISC MJO ORTHOFIX US LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Hospitalization