BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

    MDR report key: 9250601 · Received October 29, 2019

    Report

    Report Number
    9250601
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Date of Event
    October 16, 2018
    Report Date
    September 17, 2019
    Manufacturer
    CHOICE SPINE, LP
    Product Code
    ODP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CERVICAL CAGE BROKE DURING IMPLANTATION. SURGEON TRIED A SECOND CAGE, WHICH BROKE AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046394 INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP CHOICE SPINE, LP

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA