BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTURA MEDICAL TI SIRION LATERAL INTERBODY CAGE

    MDR report key: 20360405 · Received October 2, 2024

    Report

    Report Number
    MW5160481
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    January 13, 2022
    Report Date
    September 27, 2024
    Manufacturer
    ASTURA MEDICAL
    Product Code
    OVD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY DISK WAS BLOWN OUT L3-4, DUE TO A CAR ACCIDENT. THE SURGEON, PUT IN A PEAK PLASTIC CAGE, THAT I HAVE A HISTORY OF REJECTING. NOW I HAVE A PLASTIC LEVEL 10 TIMES THE SAFE LIMIT. MY TESTOSTERONE LEVEL WAS 33 AND I DEVELOPED NONALCOHOLIC FATTY LIVER. MY PANCREAS IS NOT PROCESSING SUGAR PROPERLY. MY STOMACH IS BLOATED AND I HAVE RIGHT LEG PAIN. ASTURA MEDICAL TI SIRIAN LATERAL INTERBODY CAGE WAS THE PART THE MEDICAL RECORDS SHOW WAS USED IN MY SPINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2602399 ASTURA MEDICAL TI SIRION LATERAL INTERBODY CAGE INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR OVD ASTURA MEDICAL 22842-AS

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| R| S| O TESTOSTERONE.