BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIEZOSURGERY

    MDR report key: 8325639 · Received February 11, 2019

    Report

    Report Number
    3003933619-2018-00004
    Event Type
    Malfunction
    Date Received
    February 11, 2019
    Date of Event
    July 7, 2018
    Report Date
    September 4, 2018
    Manufacturer
    MECTRON S.P.A.
    Product Code
    JDX
    PMA / PMN Number
    K153743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER ASKED BACK THE DEVICE FOR THE INVESTIGATION BUT THE HANDPIECE FOR PLUS CHANNEL, SN: (B)(4), WAS NOT RETURNED. NOT DAMAGES OCCURRED ON THE PATIENT.

    Description of Event or Problem · 1

    SCOLIOSIS CORRECTION SURGERY IN PATIENT (B)(6) YEARS OLD. PIEZOSURGERY MEDICAL PLUS HANDPIECE FAILED WHEN IT WAS CONNECTED IN THE PIEZOSURGERY PLUS. TWO MT4 - 10+ INSERTS WAS USED BUT THE HANDPIECE DIDN'T WORK EVEN SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117846 PIEZOSURGERY HANDPIECE FOR PLUS CHANNEL PIEZOSURGERY PLUS JDX MECTRON S.P.A. 03120219

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR