BEUDAMED
    FDA Adverse Event Death Summary report: N

    HINGED TIP CURETTE-8MM SWEEP

    MDR report key: 489917 · Received October 15, 2003

    Report

    Report Number
    2520274-2003-00035
    Event Type
    Death
    Date Received
    October 15, 2003
    Date of Event
    September 19, 2003
    Report Date
    September 19, 2003
    Manufacturer
    SYNTHES (USA)
    Product Code
    FZS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON COMPLAINED THAT A PATIENT EXPIRED DURING A THREE LEVEL VERTEBRAL BODY AUGMENTATION USING SYNTHES CAVITY CREATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HINGED TIP CURETTE-8MM SWEEP CURETTES FZS SYNTHES (USA) NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death NORIAN XR BONE VOID FILLER.