BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIFUSE HAMMER TOE DEVICE

    MDR report key: 5125645 · Received October 2, 2015

    Report

    Report Number
    3009351138-2015-00001
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    August 12, 2015
    Report Date
    October 2, 2015
    Manufacturer
    CARTIVA, INC.
    Product Code
    HWC
    PMA / PMN Number
    K142490
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ISSUE IS RELATED TO THE IMPLANTATION OF THE PROXIFUSE IN THE 3RD LESSER TOE. DURING THE IMPLANT PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE ON PLACEMENT OF THE FIRST ANCHOR. THE IMPLANT SHAFT BECAME BENT AS THE DEVICE SEPARATED FROM THE DELIVERY TOOL, PREVENTING FINAL PLACEMENT OF THE DEVICE. THE FIRST ANCHOR WAS SECURELY LODGED IN THE BONE. THE SURGEON CUT THE SUTURE AND USED A 2.4MM SCREW TO COMPLETE THE FUSION. THE PROCEDURE WAS COMPLETED WITH A MINOR DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656806 PROXIFUSE HAMMER TOE DEVICE SCREW, FIXATION, BONE HWC CARTIVA, INC. PRF-01 222114015

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other