BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHANTOM INTRAMEDULLARY NAIL SYSTEM

    MDR report key: 11778396 · Received May 5, 2021

    Report

    Report Number
    3008650117-2021-00089
    Event Type
    Injury
    Date Received
    May 5, 2021
    Report Date
    May 5, 2021
    Manufacturer
    PARAGON 28, INC.
    Product Code
    KTW
    PMA / PMN Number
    K182307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    5.5.2021: INITIAL INFORMATION RECEIVED WITH FURTHER INFORMATION EXPECTED; A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. 5.28.2021: NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED. IF FURTHER INFORMATION IS IDENTIFIED WHICH WOULD CHANGE OR ALTER INFORMATION OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    INITIAL INFORMATION RECEIVED WITH FURTHER INFORMATION EXPECTED; A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    PATIENT'S 1ST METATARSAL BROKE. BREAKAGE OF BONE OCCURED AT THE ENTRANCE POINT OF THE NAIL AT THE DISTAL END WITH NO ALLEGED MEDICAL DEVICE PRODUCT PROBLEM. SURGEON IS PLANNING A PLANTARIZING OSTEOTOMY OF THE 1ST METATARSAL DISTALLY OF THE NAIL AND MAYBE AN ADDITIONAL SHORTENING OF THE 2ND-5TH METATARSALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674289 PHANTOM INTRAMEDULLARY NAIL SYSTEM PHANTOM LAPIDUS NAIL KTW PARAGON 28, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other