BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHANTOM HINDFOOT TTC/TC NAIL SYSTEM

    MDR report key: 14366664 · Received May 11, 2022

    Report

    Report Number
    3008650117-2022-00052
    Event Type
    Injury
    Date Received
    May 11, 2022
    Date of Event
    April 11, 2022
    Report Date
    May 11, 2022
    Manufacturer
    PARAGON 28, INC.
    Product Code
    HSB
    PMA / PMN Number
    K201227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PREFERRED TERMS: (B)(4): PROLONGED SURGERY. (B)(4): ROOT CAUSE NOT ESTABLISHED.

    Description of Event or Problem · 0

    DURING A REVISION SURGERY, DEVICE WAS REPORTED AS NOT INTERFACING PROPERLY, WHICH LED TO SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954682 PHANTOM HINDFOOT TTC/TC NAIL SYSTEM SLAP HAMMER HSB PARAGON 28, INC. P99-150-2002

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention