BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON

    MDR report key: 4683369 · Received March 19, 2015

    Report

    Report Number
    4683369
    Event Type
    Malfunction
    Date Received
    March 19, 2015
    Date of Event
    March 6, 2015
    Report Date
    March 19, 2015
    Manufacturer
    BOSS INSTRUMENTS, LTD
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DOCTOR WAS USING A 5MM KERRISON INTRA OP; THE SCREW FELL OUT OF THE INSTRUMENT AND INTO THE WOUND. THE SCREW WAS FOUND AND REMOVED FROM THE WOUND. THE INSTRUMENT AND SCREW WERE REMOVED FROM THE STERILE FIELD AND GIVEN TO MATERIALS COORDINATOR. X-RAY WAS TAKEN, AND READ AS NEGATIVE BY RADIOLOGY. DOCTOR AWARE OF THE X-RAY RESULTS. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187506 KERRISON RONGEUR HTX BOSS INSTRUMENTS, LTD REF#70-0370 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR