BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC TALUS SPACER

    MDR report key: 19285330 · Received May 10, 2024

    Report

    Report Number
    3008650117-2024-00028
    Event Type
    Injury
    Date Received
    May 10, 2024
    Report Date
    May 10, 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

    Additional Manufacturer Narrative · 0

    THIS ADVERSE EVENT IS POSSIBLY DEVICE RELATED.

    Description of Event or Problem · 0

    A PATIENT SPECIFIC TALUS SPACER CLINICAL STUDY IDENTIFIED THE SUBJECT WAS DIAGNOSED WITH COMPLEX REGIONAL PAIN SYNDROME TYPE 1 APPROXIMATELY 9 MONTHS POST IMPLANTATION WITH NO ALLEGATION OF A PRODUCT DEFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870970 PATIENT SPECIFIC TALUS SPACER PATIENT SPECIFIC TALUS SPACER, SMALL, COCR QNN PARAGON 28, INC AOPSTSXXXXS AOCIA1948

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Other