BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICA SCREW

    MDR report key: 9158339 · Received October 4, 2019

    Report

    Report Number
    1043534-2019-00169
    Event Type
    Injury
    Date Received
    October 4, 2019
    Date of Event
    January 1, 2017
    Report Date
    September 12, 2019
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: JOWETT ET AL. PRELIMINARY RESULTS AND LEARNING CURVE OF THE MINIMALLY INVASIVE CHEVRON AKIN OPERATION FOR HALLUX VALGUS. THE JOURNAL OF FOOT & ANKLE SURGERY. 2017; 56: 445-452. 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 A 2017 LITERATURE ARTICLE FROM JOWETT, ET AL. TITLED,"PRELIMINARY RESULTS AND LEARNING CURVE OF THE MINIMALLY INVASIVE CHEVRON AKIN OPERATION FOR HALLUX VALGUS", THE AUTHORS REPORTED A PERIPROSTHETIC FRACTURE OCCURRED IN 1 PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952612 MICA SCREW SCREW, FIXATION, BONE HWC WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention