BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M6-C

    MDR report key: 17014320 · Received May 26, 2023

    Report

    Report Number
    3004987282-2023-00025
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    May 2, 2023
    Report Date
    May 26, 2023
    Manufacturer
    SPINAL KINETICS
    Product Code
    MJO
    UDI-DI
    00812388030049
    PMA / PMN Number
    P170036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BUILD LHR FOR CDL-637L 1675939 AEV885 WAS EXAMINED INCLUDING THE FINAL INSPECTION RECORDS AND THE IN-PROCESS MEASUREMENTS. THERE WAS NO NCMR ASSOCIATED WITH THIS LOT. THE DEVICE MET THE M6-C PRODUCT SPECIFICATION INCLUDING THE AXIAL STIFFNESS AND FLEXURAL RESISTANCE SPECIFICATIONS. A REVIEW OF THE RISK MANAGEMENT FILES WS PERFORMED RESULTING IN NO NEW RISKS IDENTIFIED. RMF 0003 REV 36 LINE 12.75 - DEVICE EXPLANTED. ADDITIONAL DETAILS OF THE EVENT HAVE BEEN REQUESTED.

    Description of Event or Problem · 0

    INFORMATION PROVIDED STATES THAT AN M6-C ARTIFICIAL CERVICAL DISC IMPLANTED IN 2021 WAS REMOVED. THE REASON FOR THE REMOVAL IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887219 M6-C ARTIFICIAL CERVICAL DISC MJO SPINAL KINETICS 6LL 1675939 00812388030049

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Other