BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCAR

    MDR report key: 8026632 · Received October 31, 2018

    Report

    Report Number
    2183449-2018-00032
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    September 25, 2018
    Report Date
    October 30, 2018
    Manufacturer
    ORTHOFIX SRL
    Product Code
    LZV
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT DURING A CASE THE PIERCE/PROBE WOULD NOT TUNE TO FREQUENCY. DURING THE REMOVAL OF THE CEMENT THE GENERATOR WOULD WORK ONLY INTERMITTENTLY. THE CASE WAS COMPLETED SUCCESSFULLY USING THE GENERATOR. THIS RESULTED IN A DELAY IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862955 OSCAR GENERATOR CASEFRAME NON-OPTICAL LZV ORTHOFIX SRL OE3000B/1

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR