BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.1MM MDI SURGICAL DRILL (STERILE)

    MDR report key: 2108197 · Received May 13, 2011

    Report

    Report Number
    2110898-2011-00058
    Event Type
    Other
    Date Received
    May 13, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 13, 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 CONCLUSION: THE DEVICE WAS NOT RETURNED TO 3M ESPE, THEREFORE, NO EVAL COULD BE CONDUCTED. THE DENTAL OFFICE HAS INDICATED THAT THIS WAS THE FIRST TIME USE OF THIS DRILL, BUT BASED ON AVAILABLE INFO, IT IS NOT CLEAR WHETHER OR NOT THE OFFICE HAD RE-STERILIZED THE DRILL PRIOR TO USE.

    Description of Event or Problem · 1

    DURING THE PLACEMENT OF A DENTAL IMPLANT, THE SUBJECT DRILL BROKE OFF, LEAVING A PIECE IN THE PT'S PALATE. THE DENTIST MADE AN INCISION AND REMOVED THE BROKEN PIECE OF THE DRILL. THE REMAINDER OF THE SURGERY WAS COMPLETED WITH A NEW DRILL WITH THE SAME LOT NUMBER WITHOUT INCIDENT.

    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