BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIIIS

    MDR report key: 2864148 · Received November 30, 2012

    Report

    Report Number
    2864148
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MONTERIS MEDICAL CORP
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF THE MONTERIS AXIIIS STEREOTACTIC MINI-FRAME FROM THE SCALP, IT WAS NOTICED THAT ONE LEG OF THE DEVICE WAS MISSING. THE LEG OF THE DEVICE HAD BROKEN AND THE BROKEN PIECE WAS FOUND IN THE PATIENT'S SCALP.THE PATIENT IS FINE: NO HARM. THE PROCEDURE TIME DID NOT NEED TO BE EXTENDED. THE PHYSICIAN NOTICED THE MISSING PLASTIC PIECE WHEN REMOVING THE SCREWS FROM THE PATIENT. THE PLASTIC PIECE THAT SURROUNDS THE SCREW WAS THE PIECE THAT BROKE OFF. THE PHYSICIAN WAS ABLE TO VISUALIZE THE PIECE MISSING WITHOUT ALTERING THE INCISION SITE. THE INCISION CREATED BY THE DEVICE NEEDED TO BE SLIGHTLY EXTENDED (APPROX 1 MM) IN ORDER TO REMOVE THE PLASTIC PIECE. THE PIECE THAT WAS RETAINED DID NOT ENTER THE SKULL- IT WAS RETAINED IN THE SCALP. THE DEVICE WAS APPLIED ON THE FRONTAL REGION OF THE SKULL, APPROXIMATELY 4-5 INCHES ABOVE THE EYE. WE HAVE NOT HAD THIS REPORTED TO US BEFORE THIS EVENT. STAFF/PHYSICIANS HAVE NO INSIGHT AS TO WHY IT HAPPENED; THERE WAS NOTHING UNUSUAL ABOUT THIS PROCEDURE. THERE WAS NO DIFFICULTY APPLYING OR REMOVING THE DEVICE. THERE WERE NO PATIENT RELATED FACTORS IDENTIFIED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIIIS NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MONTERIS MEDICAL CORP 120000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR