BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LDR SPINE ROI-C INTERBODY FUSION DEVICE

    MDR report key: 3111036 · Received April 10, 2013

    Report

    Report Number
    3004788213-2013-00003
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Manufacturer
    LDR MEDICAL
    Product Code
    ODP
    PMA / PMN Number
    K091088
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152185 LDR SPINE ROI-C INTERBODY FUSION DEVICE CERVICAL INTERBODY FUSION DEVICE ODP LDR MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1