BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M6-C

    MDR report key: 15424102 · Received September 14, 2022

    Report

    Report Number
    3004987282-2022-00062
    Event Type
    Injury
    Date Received
    September 14, 2022
    Date of Event
    December 6, 2021
    Report Date
    September 14, 2022
    Manufacturer
    SPINAL KINETICS LLC
    Product Code
    MJO
    PMA / PMN Number
    P170036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BUILD LHR FOR FG 0031-14 1944 ACF744 WERE EXAMINED INCLUDING THE FINAL INSPECTION RECORDS AND THE IN-PROCESS MEASUREMENTS. THERE WERE NO RELEVANT NCMRS ASSOCIATED WITH THIS LOT. THE DEVICES MET THE M6-C PRODUCT SPECIFICATION INCLUDING THE AXIAL STIFFNESS AND FLEXURAL RESISTANCE SPECIFICATIONS.

    Description of Event or Problem · 0

    INFORMATION PROVIDED STATES A PATIENT HAD 3-LEVEL M6-C SURGERY IN 2014. A COMPLETE DESTRUCTION OF THE IMPLANTS WAS DETERMINED DURING RADIOLOGICAL CHECK-UPS AND HAD TO AND COULD BE AT LEAST PARTIALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2474858 M6-C ARTIFICIAL CERVICAL DISC MJO SPINAL KINETICS LLC 1944

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other