BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARCO MODULAR REARFOOT SYSTEM

    MDR report key: 9916743 · Received April 2, 2020

    Report

    Report Number
    1043534-2020-00068
    Event Type
    Injury
    Date Received
    April 2, 2020
    Date of Event
    January 1, 2009
    Report Date
    March 6, 2020
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: SAXENA ET AL. LAPIDUS BUNIONECTOMY: EARLY EVALUATION OF CROSSED LAG SCREWS VERSUS LOCKING PLATE WITH PLANTAR LAG SCREW. THE JOURNAL OF FOOT & ANKLE SURGERY. (2009) 48: 170-179. 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

    IT WAS REPORTED IN AN ARTICLE BY SAXENA ET AL, TITLED, LAPIDUS BUNIONECTOMY: EARLY EVALUATION OF CROSSED LAG SCREWS VERSUS LOCKING PLATE WITH PLANTAR LAG SCREW, THAT THERE WERE 1 (2.5%) MALUNION, 1 (2.5%) NONUNION, AND 2 (5.0%) PATIENTS WHO USED ONLY A COMFORT SHOE (SOFT, WIDE, SUPPORTIVE) FOLLOWING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381176 DARCO MODULAR REARFOOT SYSTEM SCREW, FIXATION, BONE HWC WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other