BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C CERVICAL DISC PROSTHESIS

    MDR report key: 4732373 · Received April 24, 2015

    Report

    Report Number
    3004903783-2015-00006
    Event Type
    Injury
    Date Received
    April 24, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 24, 2015
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    PMA / PMN Number
    P110002
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4) - LDR SPINE USA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF LDR MEDICAL (MANUFACTURER). EXPLANTED DEVICE WAS SENT TO AN OUTSIDE LABORATORY FOR ANALYSIS PER APPROVED PROTOCOL. SURGEON INDICATED PATIENT INFECTION (B)(4) NOT LIKELY DUE TO THE DEVICE.

    Description of Event or Problem · 1

    REVISION SURGERY TO REMOVE AND REPLACE CERVICAL DISC ARTHROPLASTY DUE TO INFECTION AT TREATMENT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274619 MOBI-C CERVICAL DISC PROSTHESIS MOBI-C CERVICAL DISC MJO LDR MEDICAL MB3555 5238565

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other