BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4643626 · Received March 19, 2015

    Report

    Report Number
    4643626
    Event Type
    Malfunction
    Date Received
    March 19, 2015
    Date of Event
    October 14, 2014
    Report Date
    March 19, 2015
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE DRILL BIT ADAPTER FOR THE MIDAS REX SURGICAL DRILL FAILED WHILE IN USE. THERE WAS NO HARM TO THE PATIENT. THE DRILL BIT ADAPTER WAS REMOVED FROM SERVICE AND GIVEN TO THE MATERIALS COORDINATOR. ANOTHER MIDAS REX DRILL WAS OBTAINED. THE PHYSICIAN WAS AWARE OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188829 * BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF MEDTRONIC XOMED, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR