BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGHTROPE

    MDR report key: 2181645 · Received July 13, 2011

    Report

    Report Number
    2181645
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH APPROXIMATELY ONE YEAR HISTORY POST PLATING AND ARTHREX TIGHTROPE REPAIR OF SYNDESMOSIS FRACTURE WITH 20% PLAFOND BREAK AND SUBSEQUENT STAPHYLOCOCCAL INFECTION TO SITE WITH DIAGNOSIS OF OSTEOMYELITIS OF THE DISTAL TIBIA AND FIBULA. PT UNDERWENT RECENT SURGERY TO AFFECTED SITE FOR DEBRIDEMENT AND REMOVAL OF TIGHTROPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIGHTROPE ARTHREX TIGHTROPE HTN ARTHREX, INC. AR-8921CDS 06918

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R