BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-COUPLING GAUTHIER 103800

    MDR report key: 1950226 · Received December 9, 2010

    Report

    Report Number
    9615741-2010-00065
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 3, 2010
    Report Date
    December 9, 2010
    Manufacturer
    NEWDEAL
    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 EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE T HANDLE QUICK COUPLING DEVICE BROKE WHEN THEY WANTED TO REMOVE THE SCREW DURING A SURGICAL PROCEDURE. THE SURGICAL PROCEDURE WAS PROLONGED BY ABOUT TWO HOURS. INTEGRA HAS REQUESTED ADD'L INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK-COUPLING GAUTHIER 103800 NA LXH NEWDEAL EAFF

    Patients

    Seq Age Sex Outcome Treatment
    1