BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.1MM MDI SURGICAL DRILL (STERILE)

    MDR report key: 2101189 · Received May 19, 2011

    Report

    Report Number
    2110898-2011-00069
    Event Type
    Other
    Date Received
    May 19, 2011
    Date of Event
    March 30, 2011
    Report Date
    May 19, 2011
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    DZA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS, RESULTS, AND CONCLUSIONS: THE DEVICE WAS NOT RETURNED TO 3M ESPE, THEREFORE, NO EVALUATION COULD BE CONDUCTED.

    Description of Event or Problem · 1

    ON 05/11/2011, 3M ESPE WAS NOTIFIED THAT DURING PLACEMENT OF DENTAL IMPLANTS ON (B)(6) 2011, THE SUBJECT DRILL BROKE IN THE PATIENT'S MANDIBLE. THE DENTIST MADE AN INCISION AND REMOVED THE BROKEN PIECE OF THE DRILL.

    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 3511082-55

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention