BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZAVATION INTERBODY DEVICE

    MDR report key: 7063490 · Received November 28, 2017

    Report

    Report Number
    MW5073588
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    January 25, 2017
    Report Date
    November 22, 2017
    Manufacturer
    ZAVATION
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FAILURE TO FUSE. WILL REQUIRE A 360 REVISION (ADD'L SURGERY). BECAUSE I DIDN'T DEVELOP BONY FUSION, MOVEMENT IN THE HARDWARE RESULTED IN A PARS FRACTURED WHICH HAS NOT HEALED AND ADDS TO THE PAIN OF THE NON-FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842001 ZAVATION INTERBODY DEVICE SPINAL DEVICE KWQ ZAVATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention