BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C CERVICAL DISC PROSTHESIS

    MDR report key: 5494189 · Received March 10, 2016

    Report

    Report Number
    3004903783-2016-00008
    Event Type
    Injury
    Date Received
    March 10, 2016
    Date of Event
    February 8, 2016
    Report Date
    March 8, 2016
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    PMA / PMN Number
    P110002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2014039 - LDR SPINE USA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF LDR MEDICAL (MANUFACTURER). REVIEW OF THE PRE-REVISION X-RAYS PROVIDED AND COMMENTS FROM THE SURGEON INDICATE THAT THE PATIENT HAD DEVELOPED FACET DISEASE AND WAS EXPERIENCING NECK PAIN. SURGEON DECIDED TO REMOVE AND REPLACE WITH FUSION AT C5/C6. 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 DEVICE AND REPLACE WITH FUSION TREATMENT DUE PATIENT'S NECK PAIN AND SOME RADICULAR SYMPTOMS DUE TO FACET ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149779 MOBI-C CERVICAL DISC PROSTHESIS MOBI-C CERVICAL DISC MJO LDR MEDICAL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention