BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO-TOE

    MDR report key: 9012294 · Received September 12, 2019

    Report

    Report Number
    1043534-2019-00127
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    January 1, 2015
    Report Date
    August 15, 2019
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HWC
    PMA / PMN Number
    K101165
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: BASILE ET AL. INTRAMEDULLARY FIXATOIN SYSTEM FOR THE TREATMENT OF HAMMERTOE DEFORMITY. THE JOURNAL OF FOOT & ANKLE SURGERY. 2015; 54: 910-916. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY, IN AN ARTICLE WRITTEN BY BASILE ET AL. TITLED "INTRAMEDULLARY FIXATION SYSTEM FOR THE TREATMENT OF HAMMERTOE DEFORMITY" IT WAS REPORTED THAT ONE PATIENT HAD AN EARLY FAILURE DUE TO DISLOCATION OF THE FIXATION DEVICE. THE SURGEON OPENED THE WOUND REMOVED THE DEVICE AND USED A K-WIRE FOR FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809287 PRO-TOE SCREW, FIXATION, BONE HWC WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention