BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLS

    MDR report key: 6989674 · Received October 31, 2017

    Report

    Report Number
    3003898228-2017-00010
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Date of Event
    July 26, 2017
    Report Date
    October 20, 2017
    Manufacturer
    FH INDUSTRIE
    Product Code
    MBI
    UDI-DI
    03661489561931
    PMA / PMN Number
    K120740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CONTRÔLE DE LA TENUE DU GREFFON SOUS ARTHROSCOPIE LORS DE LA MISE EN PLACE DE LA VIS D'INTERFÉRENCE COLS : LE GREFFON NE TIENT PAS. ABLATION DE LA VIS ET DU GREFFON PUIS CONSTAT DE LA RUPTURE DE LA BANDELETTE. CONTROL OF THE GRAFT HOLD UNDER ARTHROSCOPY WHEN PLACING THE INTERFERENCE COLS SCREW: THE GRAFT DOES NOT HOLD. REMOVAL OF THE SCREW AND THE GRAFT, AND THEN NOTING THE RUPTURE OF THE ANCHORING TAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771784 COLS TENDON ANCHORING TAPE MBI FH INDUSTRIE G02531 03661489561931

    Patients

    Seq Age Sex Outcome Treatment
    1