BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C CERVICAL DISC PROSTHESIS

    MDR report key: 5506852 · Received March 17, 2016

    Report

    Report Number
    3004903783-2016-00010
    Event Type
    Injury
    Date Received
    March 17, 2016
    Date of Event
    December 4, 2015
    Report Date
    March 16, 2016
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    PMA / PMN Number
    P110009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2014039. ADDITIONAL DEVICE INFORMATION: MODEL# MB3575, LOT 5233443, EXPIRATION DATE 09/01/2019. THE PATIENT WAS EXPERIENCING NECK PAIN AND THE SURGEON DECIDED TO REMOVE AND REPLACE WITH FUSION AT C5-C7. THE DEVICE WAS SENT TO AN EXTERNAL LABORATORY FOR ANALYSIS AND RESULTS ARE PENDING.

    Description of Event or Problem · 0

    REVISION SURGERY TO REMOVE CERVICAL DISC ARTHROPLASTY DEVICES AND FUSE AT LEVELS C5-C7 DUE TO PATIENT'S NECK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163958 MOBI-C CERVICAL DISC PROSTHESIS MOBI-C CERVICAL DISC MJO LDR MEDICAL MB3595 5233455

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention