BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHANTOM HINDFOOT TTC/TC NAIL SYSTEM

    MDR report key: 14171647 · Received April 21, 2022

    Report

    Report Number
    3008650117-2022-00041
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    March 22, 2022
    Report Date
    April 22, 2022
    Manufacturer
    PARAGON 28, INC
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS: A3: UNKNOWN SEX. A4: UNKNOWN WEIGHT. B3: 3.20.2022. D2: PHANTOM ACTIVCORE NAIL. D6B: ON (B)(6) 2022. G3: 3.22.2022. H6: TYPE OF INVESTIGATION: 4109 - 4111 - 4115.

    Description of Event or Problem · 0

    A REVISION SURGERY WAS CONDUCTED DUE TO PATIENT NON-UNION WITH NO ALLEGED DEFICIENCY IN A PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956670 PHANTOM HINDFOOT TTC/TC NAIL SYSTEM PHANTOM ACTIVCORE NAIL HSB PARAGON 28, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention