BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMA INITIAL DRILL 1.5X15 NONIRR

    MDR report key: 1734785 · Received June 4, 2010

    Report

    Report Number
    3005990499-2010-00005
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Report Date
    March 19, 2010
    Manufacturer
    KEYSTONE
    Product Code
    DZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALS THE DRILL IS BROKEN IN TWO PIECES. THE DRILL BROKE AT THE LASER MARK, PERPENDICULAR TO IS AXIS NEAR THE TOP OF THE DRILL. THIS IS A KNOWN ISSUE DUE TO INHERENT NATURE OF BIT FUNCTIONALITY. IMPLANT SITE NUMBER IS NOT KNOWN, BUT BREAKAGE IS POSSIBLE, ESPECIALLY WHEN UTILIZED IN THE POSTERIOR ASPECT OF THE MOUTH DUE TO EXTREME ANGLE AND HIGH DIRECTION FORCES. THIS COMPLAINT CONDITION IS CONFIRMED; OPERATIONAL CONTEXT CONTRIBUTED TO THE EVENT. IN ADDITION, KEYSTONE DENTAL'S SURGICAL MANUAL RECOMMENDS DRILLS BE REPLACED WHEN WORN, CORRODED, DULL OR OTHERWISE COMPROMISED. (B)(4). IT IS LEFT TO THE PHYSICIAN TO TRACK INDIVIDUAL DEVICE USAGE. A REVIEW OF THE KEYSTONE DENTAL COMPLAINT DATABASE REVEALED THREE COMPLAINTS WITH THE SAME PART NUMBER AND FAILURE MODE REPORTED OVER THE PAST THREE YEARS. A DEVICE HISTORY REVIEW REVEALED THAT THIS IS THE ONLY COMPLAINT FILED UNDER LOT NUMBER 023177 OVER THE PAST THREE YEARS THIS COMPLAINT CONDITION IS CONFIRMED; HOWEVER, THIS IS A KNOWN FAILURE MODE. ROOT CAUSE IS ATTRIBUTED TO OPERATIONAL CONTEXT. NO ADVERSE TRENDS NOTED. (B)(4).

    Description of Event or Problem · 1

    DOCTOR WAS PERFORMING A PROCEDURE (DATE UNKNOWN) ON A PATIENT WHEN THE DRILL FRACTURED. THE BROKEN PORTION OF THE DRILL WAS REMOVED FROM THE PATIENT WITH THE AID OF A "SUCTION TUBE". THERE WAS NO IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMA INITIAL DRILL 1.5X15 NONIRR DZA KEYSTONE 15200 023177

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention