BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO-TOE

    MDR report key: 9013809 · Received September 12, 2019

    Report

    Report Number
    1043534-2019-00128
    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 20 PATIENTS EXPERIENCED TOE SWELLING THAT PERSISTED FOR GREATER THAN 6 MONTHS. TWO PATIENTS SHOWED PERSISTENT TOE SWELLING (DEFINED AS THE PRESENCE OF EDEMA AT THE FINAL FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796704 PRO-TOE SCREW, FIXATION, BONE HWC WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention