BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHANTOM ACTIVCORE NAIL

    MDR report key: 11661123 · Received April 13, 2021

    Report

    Report Number
    3008650117-2021-00082
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 15, 2021
    Report Date
    April 13, 2021
    Manufacturer
    PARAGON 28, INC
    Product Code
    HSB
    PMA / PMN Number
    K201227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DHR INSPECTION SIGNED 8/19/2020 AND NOTED TO BE WITHIN SPECIFICATIONS. ALL PIECES WERE ACCEPTED WITH NO NCR'S NOTED. IF ANY ADDITIONAL INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    PARAGON 28 PHANTOM NAIL WAS IMPLANTED (B)(6) 2020. PATIENT DEVELOPED AN INFECTION AND SURGEON ATTEMPTED TO REVISE IMPLANT ON (B)(6) 2021. IT WAS REPORTED THE SURGEON TYPICALLY DOES NOT USE AN END CAP, THE THREADS OF THE NAIL ARE THIN AND FINE, AND THEY COULD NOT GET THE "BOLTS" TO ENGAGE THE NAIL. SURGEON WAS NOT ABLE TO REMOVE THE IMPLANT. PATIENT WAS PRESCRIBED ANTIBIOTICS AND REFERRED TO A BIGGER HOSPITAL DOWNTOWN (B)(6) FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559030 PHANTOM ACTIVCORE NAIL PHANTOM ACTIVCORE NAIL, 11.5 X 300MM HSB PARAGON 28, INC P31-115-3000-S 5005811

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention