BEUDAMED
    FDA Adverse Event Other Summary report: N

    PIEZOSURGERY

    MDR report key: 2389422 · Received April 21, 2010

    Report

    Report Number
    3003933619-2010-07136
    Event Type
    Other
    Date Received
    April 21, 2010
    Date of Event
    March 18, 2010
    Report Date
    April 21, 2010
    Manufacturer
    MECTRON S.P.A.
    Product Code
    DZI
    Report Source
    Distributor report
    Reporter Location
    AK, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DURING A R MAX SINUS AUGMENTATION IN CONJUNCTION WITH PLACEMENT OF ONE IMPLANT FIXTURE. THE DOCTOR WAS USING AN EL2 TO ELEVATE THE MEMBRANE FROM THE SINUS FLOOR. THE EL2 (ELEVATOR) BROKE APPROX 5MM FROM THE TIP. THE TIP WAS FOUND IN A SMALL PERFORATION IN THE MEMBRANE AND WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIEZOSURGERY EL2 INSERT TIP - ACCESSORY TO PIEZOSURGERY BONE CUTTING DEVICE DZI MECTRON S.P.A. EL2 0208

    Patients

    Seq Age Sex Outcome Treatment
    1 Other