BEUDAMED
    FDA Adverse Event Summary report: N

    LDR SPINE ROI-C INTERBODY FUSION

    MDR report key: 3111227 · Received April 24, 2013

    Report

    Report Number
    3004903783-2013-00004
    Date Received
    April 24, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 24, 2013
    Manufacturer
    LDR MEDICAL
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT OF AN INFERIOR ANCHORING PLATE FRACTURE IN A 2-LEVEL RIO-C CERVICAL FUSION 2 MONTHS POST ORIGINAL SURGERY. PT IS REPORTED TO BE DOING GREAT AND NOT INTERVENTION IS PLANNED. NO FURTHER INFO WILL BE REC'D. IT IS NOTED THAT THE USE OF ROI-C IN A 2-LEVEL CONSTRUCT IS CONSIDERED OFF-LABEL USE OF THE DEVICE. CAUSE OF THE FRACTURE IS UNDER INVESTIGATION. MFR REF #3004788213-2013-00004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177505 LDR SPINE ROI-C INTERBODY FUSION CERVICAL INTERBODY FUSION DEVICE MQP LDR MEDICAL MC1005T UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK