BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCAR 3

    MDR report key: 6266006 · Received January 20, 2017

    Report

    Report Number
    6266006
    Event Type
    Malfunction
    Date Received
    January 20, 2017
    Date of Event
    October 17, 2016
    Report Date
    January 10, 2017
    Manufacturer
    ORTHOFIX INC.
    Product Code
    LZV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE OSCAR BECAME ENGAGED IN THE DISTAL MOST PORTION OF THE CEMENT AND FRACTURED. ATTEMPT TO RETRIEVE THE TIP OF THE OSCAR AND CEMENT PLUG WAS UNSUCCESSFUL AND WAS THEREFORE ABANDONED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50042 OSCAR 3 SYSTEM, CEMENT REMOVAL EXTRACTION LZV ORTHOFIX INC. WO/22724/A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR