BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHANTOM HINDFOOT TTC/TC NAIL SYSTEM

    MDR report key: 14174335 · Received April 21, 2022

    Report

    Report Number
    3008650117-2022-00042
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    March 23, 2022
    Report Date
    April 22, 2022
    Manufacturer
    PARAGON 28, INC
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    LIMITED INFORMATION.

    Description of Event or Problem · 0

    THE SURGEON HAD DIFFICULTY DURING A SURGERY CONNECTING THE REMOVAL INSTRUMENT TO THE IMPLANT WHICH CONTAINED BONY INGROWTH. ITEM 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919617 PHANTOM HINDFOOT TTC/TC NAIL SYSTEM EXPLANT ATTACHMENT, PHANTOM HINDFOOT HSB PARAGON 28, INC P31-958-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male