BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESERA 3-D PRINTED ALIF CAGE

    MDR report key: 7663513 · Received July 3, 2018

    Report

    Report Number
    MW5078247
    Event Type
    Injury
    Date Received
    July 3, 2018
    Date of Event
    June 20, 2018
    Report Date
    July 2, 2018
    Manufacturer
    RENOVIS SURGICAL TECHNOLOGIES, INC.
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RENOVIS ALIF CAGE COULD NOT WITHSTAND NORMAL AXIAL LOAD AND IN TURN, THE LATERAL ASPECT OF THE CAGE HAS FRACTURED AND IS COLLAPSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499780 TESERA 3-D PRINTED ALIF CAGE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT LUMBAR MAX RENOVIS SURGICAL TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other