BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIEZOSURGERY

    MDR report key: 1871368 · Received June 14, 2010

    Report

    Report Number
    3003933619-2010-00001
    Event Type
    Injury
    Date Received
    June 14, 2010
    Date of Event
    March 17, 2010
    Report Date
    March 22, 2010
    Manufacturer
    MECTRON S.P.A.
    Product Code
    ELC
    PMA / PMN Number
    K052518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSERT OT4 ARRIVED ON 05/13/2010 AT MECTRON FOR INVESTIGATION. THE INSERT WAS BROKEN OFF BUT WE FOUND THE FRAGMENTS. ACCORDING TO THE DENTIST'S COMPLAINT THE INSERT HAD TO BE SURGICALLY REMOVED AT THE IMPLANT SITE FROM A BUCCAL APPROACH. THE PT HAS NOT REPORTED ANY DAMAGE. THE LOT NUMBER OF THE INSERT IS 12/08 CORRESPONDING TO THE MANUFACTURING DATE: DECEMBER 2008. THE RETURNED INSERT WAS VISUALLY INSPECTED 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 DATE 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, A CORRECT TECHNIQUE AND LEVERAGE MADE WITH THE INSERT DURING THE OSTEOTOMY. ALL OF THESE FACTORS MAY CREATE STRESS ON THE INSERT MATERIAL AND AFFECT THE DURABILITY OF THE INSERT. BASED ON THE RECEIVED INFO AND THE CONDITION OF THE RETURNED INSERT, IT CANNOT BE DEMONSTRATED THAT THE EVENT WAS CAUSED BY USE. SEE SCANNED PAGES. ADDITIONAL INFO FROM THE IMPORTER REPORT: (B)(4): OT4 INSERT TIP - ACCESSORY TO PIEZOSURGERY BONE CUTTING DEVICE; (B)(6).

    Description of Event or Problem · 1

    (B)(4): "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 TO PIEZOSURGERY ELC MECTRON S.P.A. OT4 1208

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R