BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC TALUS SPACER

    MDR report key: 19270548 · Received May 8, 2024

    Report

    Report Number
    3008650117-2024-00027
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 5, 2024
    Report Date
    May 8, 2024
    Manufacturer
    PARAGON 28, INC
    Product Code
    QNN
    PMA / PMN Number
    H200001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A PATIENT SPECIFIC TALUS SPACER CLINICAL STUDY IDENTIFIED THE SUBJECT EXPERIENCED A DEVICE RELATED SERIOUS INJURY APPROXIMATELY 1 YEAR POST DEVICE IMPLANTATION WITH NO ALLEGATION OF A PRODUCT DEFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759023 PATIENT SPECIFIC TALUS SPACER PATIENT SPECIFIC TALUS SPACER, NOMINAL, TITANIUM QNN PARAGON 28, INC AOPSTSXXXXN-TI AOCIA1914

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Other