BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.1MM MDI SURGICAL DRILL (STERILE)

    MDR report key: 2577504 · Received May 14, 2012

    Report

    Report Number
    3005174370-2012-00013
    Event Type
    Other
    Date Received
    May 14, 2012
    Date of Event
    April 27, 2012
    Report Date
    April 27, 2012
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    DZA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT HAS A FAVORABLE CLINICAL USE HISTORY, WITH ONLY INFREQUENT REPORTS OF DRILLS BREAKING BEING REPORTED TO 3M ESPE. THE CONSULTANT IMPLANTOLOGIST AND 3M ESPE PERSONNEL DISCUSSED THE IMPORTANCE OF PROPER DRILLING TECHNIQUE (INCLUDING USE OF COPIOUS AMOUNTS OF WATER AND KEEPING THE DRILLING MOVING WHEN REMOVING FROM THE SITE) TO MINIMIZE RISK OF DRILL BREAKAGE WITH THE DENTAL PROFESSIONAL.

    Description of Event or Problem · 1

    DURING DRILLING OF A PILOT HOLE FOR THE PLACEMENT OF AN IMPLANT, ABOUT A 5MM LONG PORTION OF THE DRILL BROKE OFF IN THE MANDIBLE OF A PT. UPON CONSULTATION WITH A DENTAL IMPLANTOLOGIST, A DECISION WAS MADE TO LEAVE THE BROKEN PORTION OF THE IMPLANT IN THE JAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.1MM MDI SURGICAL DRILL (STERILE) DENTAL DRILL DZA 3M ESPE DENTAL PRODUCTS S1011 35010413

    Patients

    Seq Age Sex Outcome Treatment
    1 Other