BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LDR SPINE ROI-C INTERBODY FUSION DEVICE

    MDR report key: 3896898 · Received May 30, 2014

    Report

    Report Number
    3004903783-2014-00008
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 30, 2014
    Manufacturer
    LDR MEDICAL
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY TO ADD POSTERIOR FIXATION DUE TO ANCHOR PLATE FRACTURE. MFR # 3004788213-2014-00008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319916 LDR SPINE ROI-C INTERBODY FUSION DEVICE CERVICAL INTERBODY FUSION DEVICE MAX LDR MEDICAL MC1006T 509624

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention