BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCOMPASS

    MDR report key: 920519 · Received October 1, 2007

    Report

    Report Number
    1649384-2007-00821
    Event Type
    Malfunction
    Date Received
    October 1, 2007
    Report Date
    October 1, 2007
    Manufacturer
    ABBOTT SPINE
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION PENDING.

    Description of Event or Problem · 1

    IN 2007, THE SALES REPRESENTATIVE REPORTED THAT THE T-HANDLE HAX DRIVER WAS NO LONGER HOLDING THE CLOSURE TOPS PROPERLY. THE SALES REPRESENTATIVE IDENTIFIED THIS ON AN UNREPORTED DATE. THE SALES REPRESENTATIVE STATED THAT IT WAS DUE TO BEING USED IN SEVERAL CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCOMPASS CLOSURE TOP/SET-SCREW T-HANDLE DRIVER HXX ABBOTT SPINE NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR