BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONX AORTIC ANATOMIC 21

    MDR report key: 12656101 · Received October 19, 2021

    Report

    Report Number
    1649833-2021-00037
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    August 24, 2021
    Report Date
    December 14, 2021
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, ONXAN-21 SN (B)(6) WAS IMPLANTED ON (B)(6) 2016 AND EXPLANTED ON (B)(6) 2021. ADDITIONAL INFORMATION WAS RECEIVED, ONXAN-21 HAD TO BE REMOVED BECAUSE OF PVE (PROSTHETIC VALVE ENDOCARDITIS) IT GOT INFECTED AND THERE WAS A ROOT ABSCESS.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORT, ONXAN-21 SN (B)(4) WAS IMPLANTED ON (B)(6) 2016 AND EXPLANTED ON (B)(6) 2021. ADDITIONAL INFORMATION WAS RECEIVED, ONXAN-21 HAD TO BE REMOVED BECAUSE OF PVE (PROSTHETIC VALVE ENDOCARDITIS) IT GOT INFECTED AND THERE WAS A ROOT ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553071 ONX AORTIC ANATOMIC 21 HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXAN-21

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Other