BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C CERVICAL DISC PROSTHESIS

    MDR report key: 4143518 · Received September 4, 2014

    Report

    Report Number
    3004788213-2014-00016
    Event Type
    Injury
    Date Received
    September 4, 2014
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    PMA / PMN Number
    P110009
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    PT INVOLVED IN MOTOR VEHICLE ACCIDENT. PT WAS PARTICIPANT IN IDE STUDY FOR TDR DEVICE. DEVICE WAS OUTSIDE LAB FOR BIOLOGIC ANALYSIS PER PROTOCOL AND RESULTS TO BE REPORTED IN IDE DOCUMENTATION.

    Description of Event or Problem · 1

    REF IMP# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540414 MOBI-C CERVICAL DISC PROSTHESIS MOBI-C CERVICAL DISC MJO LDR MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1