BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M6-C CERVICAL DISC REPLACEMENT ORTHOFIX

    MDR report key: 18783774 · Received February 23, 2024

    Report

    Report Number
    MW5152001
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Report Date
    February 21, 2024
    Manufacturer
    INFINITY LABORATORIES
    Product Code
    MJO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE M6-C HAS 16 CASE REPORTS ALL NEGATIVE THE MAJORITY SPEAKING OF "CATASTROPHIC CORE COLLAPSE" AND OSTEOLYSIS. NOW THERE ARE TWO RETROSPECTIVE SERIES ONE SHOWING A 34% FAILURE AND REVISION RATE DUE TO OSTEOLYSIS AND DEVICE FAILURE (SCOTT-YOUNG, 2022) AND 10% (HACKEL, 2024). THERE ARE YOUTUBE VIDEOS BY FAMOUS SPINE SURGEONS ON THESE FAILURES? SCOTT-YOUNG M, RATHBONE E, GRIERSON L. MIDTERM OSTEOLYSIS-INDUCED ASEPTIC FAILURE OF THE M6-C¿ CERVICAL TOTAL DISC REPLACEMENT SECONDARY TO POLYETHYLENE WEAR DEBRIS. EUR SPINE J. 2022 MAY;31(5):1273-1282. DOI: 10.1007/S00586-021-07094-7. EPUB 2022 JAN 12. PMID: 35020078. HÄCKEL S, GAFF J, PABBRUWE M, CELENZA A, KERN M, TAYLOR P, MILES A, CUNNINGHAM G. HETEROTOPIC OSSIFICATION, OSTEOLYSIS AND IMPLANT FAILURE FOLLOWING CERVICAL TOTAL DISC REPLACEMENT WITH THE M6-C¿ ARTIFICIAL DISC. EUR SPINE J. 2024 FEB 16. DOI: 10.1007/S00586-024-08129-5. CHECK THE YOUTUBE LINK: HTTPS://WWW.YOUTUBE.COM/WATCH?V=KEIMWWGPZMQ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110727 M6-C CERVICAL DISC REPLACEMENT ORTHOFIX PROSTHESIS, INTERVERTEBRAL DISC MJO INFINITY LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other