BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHANTOM HINDFOOT TTC/TC NAIL SYSTEM

    MDR report key: 14593594 · Received June 3, 2022

    Report

    Report Number
    3008650117-2022-00061
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 5, 2022
    Report Date
    June 3, 2022
    Manufacturer
    PARAGON 28, INC
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBER ADDED, 91576982003049. D9: RECEIVED BY PARAGON 28. DEVICE AVAILABLE FOR EVALUATION. G4: COMBINATION PRODUCT SHOULD NOT BE CHECKED. IT WILL NOT UNCHECK. H2: FOLLOWUP TO ADD NEW "INFORMATION" AND EVALUATION. H3: PRODUCT EVALUATED.

    Description of Event or Problem · 0

    MATING DIFFICULTY OCCURRED BETWEEN A NAIL AND EXPLANT ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801476 PHANTOM HINDFOOT TTC/TC NAIL SYSTEM EXPLANT ATTACHMENT HSB PARAGON 28, INC 91576982003049

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male