BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIEZOSURGERY

    MDR report key: 8353131 · Received February 20, 2019

    Report

    Report Number
    3003933619-2018-00009
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    October 15, 2018
    Report Date
    January 9, 2019
    Manufacturer
    MECTRON S.P.A.
    Product Code
    JDX
    PMA / PMN Number
    K132848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER MECTRON S.P.A. RECEIVED THE INSERT INVOLVED IN THE EVENT. AN INVESTIGATION WAS CARRY OUT BY THE MANUFACTURER: THE INSERT RETURNED, MT1-10, LOT. NUMBER 18002205, WAS ANALYSED BY AN EXTERNAL LABORATORY. THE RESULT OF THIS ANALYSIS DIDN'T REVEAL ANY CRITICAL PROBLEM ON THE STRUCTURE OF THE INSERT. MOREOVER THE DESIGN, PRODUCTION, IN-PROCESS AND FINAL CONTROLS DOCUMENTS, RELATED TO THE INSERT MT1-10, LOT 18002205 DIDN'T SHOW ANY ANOMALY.

    Description of Event or Problem · 1

    DURING THE USE IN A MAXILLOFACIAL SURGERY, THE INSERT MT1-10, LOT N. 18002205, EXPIRATION DATE 30 JULY 2023, ETO STERILIZATION BATCH (B)(4), BROKE. NO ADVERSE EVENT OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149382 PIEZOSURGERY MT1-10, INSERT FOR GENERAL BONE SURGERY JDX MECTRON S.P.A. MT1-10 18002205

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR