BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIEZOSURGERY

    MDR report key: 1945923 · Received November 11, 2010

    Report

    Report Number
    3003933619-2010-00003
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    MECTRON S.P.A.
    Product Code
    ELC
    PMA / PMN Number
    K052518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT HAPPENED DURING AN IMPLANT PLACEMENT PROCEDURE. THE BROKEN INSERT TIP FRAGMENTS WAS RETRIEVED FROM THE SURGICAL SITE WITHOUT HARM TO PT. THE INSERT ARRIVED TO THE MANUFACTURER, MECTRON S.P.A., FOR MORE INVESTIGATION. THE OP5 INSERT WAS VISUALLY INSPECTED BY TECHNICIAN OF MECTRON S.P.A. AND NO ABNORMALITIES WERE NOTED (NO SCRATCHING AND DEFORMATION WERE FOUND ON THE BROKEN INSERT THAT COULD TRACE THE BREAKAGE BACK TO A MATERIAL CRACK/DEFECT). THE LOT NUMBER OF THE INSERT IS 1008 CORRESPONDING TO THE MANUFACTURING DATE: 10/2008. THE DATA CONTAINED IN THE CASTING CERTIFICATE RELATIVE TO THE MATERIAL BY WHICH THE SUBJECT INSERT LOT WAS MANUFACTURED ARE IN CONFORMITY WITH THE INSERT DESIGN REQUIREMENTS. SEVERAL FACTORS MAY CONTRIBUTE TO THE INSERT BREAKAGE SUCH AS AN EXCESSIVE PRESSURE APPLIED, AN INCORRECT TECHNIQUE AND LEVERAGE MADE WITH THE INSERT DURING THE SURGERY, OR THE HANDPIECE WAS ACTIVATED WHILE THE INSERT IN CONTACT WITH THE PART TO BE TREATED. USER TECHNIQUE MAY HAVE CONTRIBUTED TO THE EVENT. ALL OF THESE FACTORS MAY CREATE STRESS ON THE INSERT MATERIAL AND AFFECT THE DURABILITY OF THE INSERT. BASED UPON THE INFO RECEIVED, DETERMINATION OF WHETHER THE EVENT WAS CAUSED BY USE FACTORS CANNOT BE MADE. ADDITIONAL INFO FROM THE IMPORTER REPORT: (B)(4): OP5 INSERT TIP - ACCESSORY TO PIEZOSURGERY BONE CUTTING DEVICE, PRODUCT CODE: DZI. (B)(4).

    Description of Event or Problem · 1

    "DURING IMPLANT PLACEMENT, THE OP5 INSERT WAS USED. THIS WAS A NEW INSERT AND HAD NOT YET BEEN USED. THE PIEZO INSERT TIP BROKE 11 MM DEEP INTO THE BONE. DUE TO THIS, THE DOCTOR HAD TO REMOVE ADDITIONAL BONE TO REMOVE THE TIP. THIS ALSO RESULTED IN THE SURGERY TIME BEING LONGER TO REMOVE THE INSERT TIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIEZOSURGERY OP5 - INSERT TO PIEZOSURGERY ELC MECTRON S.P.A. OP5 1008

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention