BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.1MM MDI SURGICAL DRILL (STERILE)

    MDR report key: 2713534 · Received August 21, 2012

    Report

    Report Number
    3005174370-2012-00017
    Event Type
    Other
    Date Received
    August 21, 2012
    Date of Event
    July 19, 2012
    Report Date
    July 23, 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
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS, RESULTS AND CONCLUSIONS: A PORTION OF THE BROKEN PRODUCT WAS RETURNED TO 3M FOR EVAL. THE FRACTURE OCCURRED AT THE BASE (START) OF THE FLUTES. THE DIAMETER CROSS-SECTION AT THE FRACTURE WAS MEASURED TO BE WITHIN SPCS.

    Description of Event or Problem · 1

    WHILE DRILLING FOR IMPLANT PLACEMENT, THE S1011 DRILL FRACTURED AND THE REMAINING FRAGMENT WAS REMOVED WITH USE OF A DENTAL BUR. THE DRILL WAS NEW AND IT WAS THE FIRST USE. NO INDICATION OF THE DENSITY OF THE PT'S BONE WAS PROVIDED TO 3M ESPE.

    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 S1101 N332179

    Patients

    Seq Age Sex Outcome Treatment
    1 Other