BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.1MM MDI SURGICAL DRILL (STERILE)

    MDR report key: 2255245 · Received September 12, 2011

    Report

    Report Number
    3005174370-2011-00006
    Event Type
    Other
    Date Received
    September 12, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 19, 2011
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    DZA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, 3M ESPE WAS NOTIFIED THAT DURING PRE-DRILLING FOR IMPLANT IMPLANTATION, A DRILL (TYPE S1011) GOT STUCK IN THE SUBSTANTIA COMPACTS AND BROKE WHILE TRYING TO REMOVE. IN A FOLLOWING X-RAY EXAMINATION, IT WAS FOUND THAT THE DRILL FRAGMENT HAS CONTACT TO A NEIGHBORING IMPLANT (TYPE OB-13). THEREFORE THE IMPLANT WAS REMOVED AND THE DRILL FRAGMENT REMAINING IN THE BONE WAS MILLED OUT. ACCORDING TO INFO PROVIDED BY THE DENTAL PROFESSIONAL, THE HEALTH STATUS OF THE PT IS FINE AND NO DETAILS ON WHETHER ADD'L IMPLANTS WILL BE PLACED WERE 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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention