BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LDR SPINE ROI-C INTERBODY FUSION DEVICE

    MDR report key: 3162623 · Received May 8, 2013

    Report

    Report Number
    3004903783-2013-00006
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 8, 2013
    Manufacturer
    LDR MEDICAL
    Product Code
    ODP
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT OF AN INFERIOR ANCHORING PLATE FRACTURE IN A 2-LEVEL ROI-C CERVICAL FUSION TWO MONTHS POST ORIGINAL SURGERY. REVISION SURGERY WAS PERFORMED ON (B)(6) 2013, TO REMOVE THE ROI-C CONSTRUCT AT C6-C7. IT IS NOTED THAT THE USE OF ROI-C IN A 2-LEVEL CONSTRUCT IS CONSIDERED OFF-LABEL USE OF THE DEVICE. INVESTIGATION IS ON-GOING. REF 304788213-2013-00006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202476 LDR SPINE ROI-C INTERBODY FUSION DEVICE CERVICAL INTERBODY FUSION DEVICE ODP LDR MEDICAL MC1005T 501214 OR 504416

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention