BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON RONGEUR

    MDR report key: 7490060 · Received May 7, 2018

    Report

    Report Number
    7490060
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    April 25, 2018
    Report Date
    May 1, 2018
    Manufacturer
    LIFE INSTRUMENT CORP.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NUMBER 3 KERRISON SCREW BACKED OUT WHEN BEING USED BY SURGEON, HANDLE FELL APART. XRAY (FLAT PLATE) TAKEN AND READ BY RADIOLOGIST. KERRISON BROUGHT TO OFFICE WITH PATIENT'S STICKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334086 KERRISON RONGEUR RONGEUR, MANUAL JXG LIFE INSTRUMENT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR