BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIEZOSURGERY

    MDR report key: 2389421 · Received April 15, 2010

    Report

    Report Number
    3003933619-2010-07119
    Event Type
    Malfunction
    Date Received
    April 15, 2010
    Date of Event
    March 17, 2010
    Report Date
    April 14, 2010
    Manufacturer
    MECTRON S.P.A.
    Product Code
    DZI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DURING A PILOT OSTEOTOMY AXIS SURGERY PREPARATION, A PIEZOSURGERY OT4 INSERT TIP FRACTURED, LEAVING THE TIP WEDGED INTO THE BASE OF THE OSTEOTOMY NEAR THE SINUS FLOOR. THE TIP HAD TO BE SURGICALLY REMOVED AT THE IMPLANT SITE FROM A BUCCAL APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIEZOSURGERY OT4 INSERT TIP - ACCESSORY TO PIEZOSURGERY BONE CUTTING DEVICE, DZI MECTRON S.P.A. OT4 1208

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR