BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIEZOSURGERY

    MDR report key: 1871386 · Received June 14, 2010

    Report

    Report Number
    3003933619-2010-00002
    Event Type
    Malfunction
    Date Received
    June 14, 2010
    Date of Event
    March 18, 2010
    Report Date
    March 25, 2010
    Manufacturer
    MECTRON S.P.A.
    Product Code
    ELC
    PMA / PMN Number
    K052518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A R MAX SINUS AUGMENTATION IN CONJUNCTION WITH PLACEMENT OF ONE IMPLANT FIXTURE. THE DR WAS USING AN EL2 TO ELEVATE THE MEMBRANE FROM THE SINUS FLOOR. THE DENTIST WAS USING THE INSERT EL2 TO ELEVATE THE MEMBRANE FROM THE SINUS FLOOR. THE FRAGMENT OF THE INSERT WAS FOUND IN A SMALL PERFORATION IN THE MEMBRANE AND WAS RETRIEVED. THE BROKEN TIP WAS NOT RETURNED TO THE MANUFACTURER MECTRON. NO EVALUATION ON THE ACTUAL PART INVOLVED IN THE EVENT IS POSSIBLE. THE PT HAS NOT REPORTED DAMAGE. ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: (B)(4): EL2 INSERT TIP - ACCESSORY TO PIEZOSURGERY BONE CUTTING DEVICE. (B)(4).

    Description of Event or Problem · 1

    "DURING A R MAX SINUS AUGMENTATION IN CONJUNCTION WITH PLACEMENT OF ONE IMPLANT FIXTURE. THE DR WAS USING AN EL2 TO ELEVATE THE MEMBRANE FROM THE SINUS FLOOR. THE EL2 (ELEVATOR) BROKE APPROX 5 MM 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 TO PIEZOSURGERY ELC MECTRON S.P.A. EL2 0208

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other