BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI TITAMAX EX ACQUA IMPLANT (4.1)3.75X13

    MDR report key: 7498044 · Received May 9, 2018

    Report

    Report Number
    3008261720-2018-02099
    Event Type
    Injury
    Date Received
    May 9, 2018
    Date of Event
    February 28, 2018
    Report Date
    May 9, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016366
    PMA / PMN Number
    K133592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS USED MORE DRILLS THAN RECOMMENDED TO PERFORM THE IMPLANT INSTALLATION.

    Description of Event or Problem · 0

    RP 011788 - THE DENTIST REPORTED THAT AFTER 5 MONTHS DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 13#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED BONE TYPE IV, BONE GRAFT WAS EXECUTED AND IMMEDIATE IMPLANT WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340055 TI TITAMAX EX ACQUA IMPLANT (4.1)3.75X13 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 19961 07899878016366

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention