BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X PROSTHETIC AORTIC VALVE WITH ANATOMIC SEWING RING WITH EXTENDED HOLDER

    MDR report key: 24376605 · Received February 18, 2026

    Report

    Report Number
    1649833-2026-00004
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    January 6, 2026
    Report Date
    April 23, 2026
    Manufacturer
    ONX LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    UDI-DI
    00851788001662
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, AN AORTIC IMPLANT REGISTRATION CARD WAS RECEIVED FOR A PATIENT WITH AN EXISTING AORTIC IMPLANT, INDICATING THE ORIGINAL WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438236 ON-X PROSTHETIC AORTIC VALVE WITH ANATOMIC SEWING RING WITH EXTENDED HOLDER HEART-VALVE, MECHANICAL LWQ ONX LIFE TECHNOLOGIES, INC. ONXANE-23 00851788001662

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention