BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHANTOM HINDFOOT TTC/TC NAIL SYSTEM

    MDR report key: 12582757 · Received October 6, 2021

    Report

    Report Number
    3008650117-2021-00117
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    September 15, 2021
    Report Date
    October 6, 2021
    Manufacturer
    PARAGON 28, INC
    Product Code
    HSB
    PMA / PMN Number
    K201227
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THREADING ISSUE WITH THE SLAP HAMMER DELAYED SURGERY 45 MINUTES; LIMITED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484865 PHANTOM HINDFOOT TTC/TC NAIL SYSTEM SLAP HAMMER HSB PARAGON 28, INC P99-150-2002 9156883

    Patients

    Seq Age Sex Outcome Treatment
    1