BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC TOTAL TALUS

    MDR report key: 20041663 · Received August 22, 2024

    Report

    Report Number
    3008650117-2024-00029
    Event Type
    Injury
    Date Received
    August 22, 2024
    Report Date
    August 22, 2024
    Manufacturer
    PARAGON 28, INC
    Product Code
    QNN
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B-NOTE, THIS IS A CUSTOM DEVICE THAT IS 510K EXEMPT.

    Description of Event or Problem · 0

    THE PATIENT HAD A REACTION TO THE CUSTOM TOTAL TALUS. THE TOTAL TALUS WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381199 PATIENT SPECIFIC TOTAL TALUS QNN PARAGON 28, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other