BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVAMAX PLUS

    MDR report key: 1217783 · Received October 22, 2008

    Report

    Report Number
    1217783
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 22, 2008
    Manufacturer
    CARDINAL HEALTH MEDICAL PRODUCTS & SERVICES
    Product Code
    OAR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS INJECTING CEMENT DURING VERTEBROPLASTY WHEN THE DELIVERY SYSTEM BROKE. THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAMAX PLUS BONE CEMENT DELIVERY SYSTEM, ORTHOPEDIC OAR CARDINAL HEALTH MEDICAL PRODUCTS & SERVICES 11G13G L8L271

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR