BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSE BONE GRAFT/LT-CAGE

    MDR report key: 5317918 · Received December 22, 2015

    Report

    Report Number
    5317918
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    December 4, 2015
    Report Date
    December 15, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    OJZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS LATERAL, LEFT SIDE UP. DOCTOR STATED THAT THE CAGE BROKE. MANUFACTURER RESPONSE FOR CAGE, (BRAND NOT PROVIDED) (PER SITE REPORTER): MANUFACTURER TO REPLACE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844990 INFUSE BONE GRAFT/LT-CAGE FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH ME OJZ MEDTRONIC SOFAMOR DANEK USA, INC. 21AJ

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR