BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL FOR DISTRUCTION SCREW

    MDR report key: 617307 · Received June 13, 2005

    Report

    Report Number
    617307
    Event Type
    Malfunction
    Date Received
    June 13, 2005
    Date of Event
    May 25, 2005
    Report Date
    June 13, 2005
    Manufacturer
    T. KOROS SURGICAL INSTRUMENTS CORP
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DRILL BIT WAS DEFECTIVE. THE DRILL BIT TIP WAS TWICE AS LONG AS DESIGN SPECIFICATION. THE DRILL BIT TIP WAS NOT PERMANENTLY CONNECTED AT THE END OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL FOR DISTRUCTION SCREW DRILL BIT HTW T. KOROS SURGICAL INSTRUMENTS CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR