BEUDAMED
    FDA Adverse Event Other Summary report: N

    STAINLESS STEEL DRILL

    MDR report key: 27558 · Received October 11, 1995

    Report

    Report Number
    27558
    Event Type
    Other
    Date Received
    October 11, 1995
    Date of Event
    August 17, 1995
    Report Date
    September 28, 1995
    Manufacturer
    TMJ IMPLANTS, INC.
    Product Code
    DZI
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE DR WAS USING THE DRILL BIT, THE TIP BROKE OFF IN THE RIGHT SIDE TMJ. UNABLE TO RETRIEVE, LEFT IN PLACE AS PART OF THE IMPLANT. SMALL PORTION OF THE DRILL BIT BROKE DURING USE. DR STATED THAT IT WOULD BE MORE TRAUMATIC TO RETRIEVE THE PIECE & THAT THE PIECE LEFT BEHIND SHOULD NOT CAUSE A REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAINLESS STEEL DRILL DRILL DZI TMJ IMPLANTS, INC. #4-016

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other