BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SMART IMPLANT (4.3) 4.2X11.5

    MDR report key: 4397062 · Received November 13, 2014

    Report

    Report Number
    3010593814-2014-00312
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 13, 2014
    Manufacturer
    AVENIDA JUSCELINO KUBITSCHEK DE OLI
    Product Code
    DZE
    PMA / PMN Number
    K133510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DENTIST REPORTED THAT AFTER THE DENTAL IMPLANT WAS PLACED IN THE PATIENT BONE, IT WAS VERIFIED NON-OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734781 DRIVE SMART IMPLANT (4.3) 4.2X11.5 ENDOSSEOUS DENTAL IMPLANT DZE AVENIDA JUSCELINO KUBITSCHEK DE OLI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention