BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-COUPLING GAUTHIER 103800

    MDR report key: 2321698 · Received October 27, 2011

    Report

    Report Number
    9615741-2011-00059
    Event Type
    Malfunction
    Date Received
    October 27, 2011
    Date of Event
    October 13, 2011
    Report Date
    October 27, 2011
    Manufacturer
    INTEGRA, SAINT PRIEST
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE T HANDLE OF THE DEVICE BROKE DURING USE IN A SURGICAL PROCEDURE TO REMOVE A QWIX SCREW. THE SAME ISSUE HAPPENED WHEN THEY IMPLANTED THE SCREW INTO THE PT. THERE WAS NO INJURY TO THE PT. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK-COUPLING GAUTHIER 103800 NA LXH INTEGRA, SAINT PRIEST EAFF

    Patients

    Seq Age Sex Outcome Treatment
    1