BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICA SCREW

    MDR report key: 9168981 · Received October 8, 2019

    Report

    Report Number
    1043534-2019-00171
    Event Type
    Injury
    Date Received
    October 8, 2019
    Date of Event
    January 1, 2019
    Report Date
    September 11, 2019
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: FRIGG ET AL.STIFFNESS AND RANGE OF MOTION AFTER MINIMALLY INVASIVE CHEVRON-AKIN AND OPEN SCARF-AKIN PROCEDURES. FOOT & ANKLE INTERNATIONAL. 2019; 00: (0). 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 2019 LITERATURE ARTICLE FROM FRIGG ET AL.TITLED,"STIFFNESS AND RANGE OF MOTION AFTER MINIMALLY INVASIVE CHEVRON-AKIN AND OPEN SCARF-AKIN PROCEDURES" THE AUTHORS REPORT SCREW REMOVAL IN 16 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962668 MICA SCREW SCREW, FIXATION, BONE HWC WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention