BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M6-C

    MDR report key: 15842958 · Received November 22, 2022

    Report

    Report Number
    3004987282-2022-00072
    Event Type
    Injury
    Date Received
    November 22, 2022
    Date of Event
    October 27, 2022
    Report Date
    November 21, 2022
    Manufacturer
    SPINAL KINETICS
    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 FFG 0031-10 1449 ACD855 WAS 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 THAT PATIENT HAD TWO LEVEL ARTIFICIAL CERVICAL DISC REPLACEMENT SURGERY IN (B)(6) 2014. PT COMPLAINED OF PERSISTENT AND THERAPY-RESISTANT PAIN IN HIS LEFT ARM SINCE THE BEGINNING OF 2022. ON EXAMINATION, SENSORY AND MOTOR DEFICITS FOR THE C7 NERVE ROOT ON THE LEFT WERE FOUND. X-RAY IMAGES REVEAL LOSS OF HEIGHT IN BOTH IMPLANTS AND PARTIAL DISSOLUTION OF THE CORE OF THE SUPERIOR ENDPLATE OF DISC AT C6/7. THE DEVICES WERE EXPLANTED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2781565 M6-C ARTIFICIAL CERVICAL DISC MJO SPINAL KINETICS 1449

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Other