BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVAMAX

    MDR report key: 1644401 · Received March 5, 2010

    Report

    Report Number
    1644401
    Event Type
    Malfunction
    Date Received
    March 5, 2010
    Date of Event
    January 15, 2010
    Report Date
    March 5, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A VERTEBROPLASTY, THE HANDLE OF THE STYLET BROKE OFF OF THE NEEDLE. THE PHYSICIAN WAS ABLE TO REMOVE THE STYLET WITHOUT INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAMAX DISPENSER, CEMENT, STYLET KIH CARDINAL HEALTH * L9J309

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR