BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAMAX SMART IMPLANT (4.1) 4.0X11

    MDR report key: 7508920 · Received May 11, 2018

    Report

    Report Number
    3008261720-2018-02204
    Event Type
    Injury
    Date Received
    May 11, 2018
    Date of Event
    January 25, 2018
    Report Date
    May 11, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237566764
    PMA / PMN Number
    K133510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORTON BEHALF OF NEODENT - JJGC. CONSIDERING THE SURGICAL METHODOLOGY, ITWAS SEEN THAT THE DENTIST HAS SELECTED AN IMPLANT DESIGN WHICH IS NOTRECOMMENDED FOR THE PATIENT'S BONE QUALITY.

    Description of Event or Problem · 0

    RP 011801 - THE DENTIST REPORTED THAT AFTER 3 MONTHS DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 26#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED BONE TYPE III.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349991 TITAMAX SMART IMPLANT (4.1) 4.0X11 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800132591 07898237566764

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention