BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LDR SPINE ROI-C INTERBODY FUSION DEVICE

    MDR report key: 4143546 · Received September 5, 2014

    Report

    Report Number
    3004903783-2014-00017
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    October 10, 2011
    Report Date
    September 5, 2014
    Manufacturer
    LDR MEDICAL
    Product Code
    OVE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY TO REMOVE MIGRATED 'TANG' OF ACDF DEVICE DUE TO PT INVOLVED IN AUTO ACCIDENT. MFR REF# 3004788213-2014-00017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544309 LDR SPINE ROI-C INTERBODY FUSION DEVICE CERVICAL INTERBODY FUSION DEVICE OVE LDR MEDICAL MC1005T 478354 OR 478353

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention