BEUDAMED
    FDA Adverse Event Death Summary report: N

    OSSURE LOEP KIT

    MDR report key: 9604847 · Received January 18, 2020

    Report

    Report Number
    3011662387-2020-00001
    Event Type
    Death
    Date Received
    January 18, 2020
    Date of Event
    December 19, 2019
    Report Date
    January 18, 2020
    Manufacturer
    AGNOVOS HEALTHCARE USA, LLC
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE OSSURE LOEP KIT IS NOT MARKETED IN THE UNITED STATES, AND IT IS ONLY EXPORTED FROM THE USA. THE IMPLANT MATERIAL IN THE OSSURE LOEP KIT IS EQUIVALENT TO THE IMPLANT MATERIAL IDENTIFIED IN 510(K) #K181342.

    Description of Event or Problem · 1

    PATIENT UNDERWENT BILATERAL LOCAL OSTEO-ENHANCEMENT PROCEDURE (LOEP). SHORTLY AFTER FINISHING THE PROCEDURE, PATIENT BECAME UNSTABLE (~16H40) AND WAS TRANSFERRED TO INTENSIVE CARE AT AROUND 18H00. AN ECHOCARDIOGRAM SHOWED HEART IN A REALLY WEAK STATE, A CONDITION PREVIOUSLY UNKNOWN TO FAMILY OR TREATING PHYSICIAN. PATIENT WAS TREATED WITH LEVOPHED AND REANIMATED MULTIPLE TIMES. PATIENT DECEASED AT AROUND 22H15. SURGEON REPORTED TO AGNOVOS THAT THE DEATH WAS NOT RELATED TO THE OSSURE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67733 OSSURE LOEP KIT AGN1 LOEP KIT MQV AGNOVOS HEALTHCARE USA, LLC 2018000085

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death