BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI TITAMAX IMPLANT (4.1)3.75X9

    MDR report key: 7504195 · Received May 10, 2018

    Report

    Report Number
    3008261720-2018-02166
    Event Type
    Injury
    Date Received
    May 10, 2018
    Date of Event
    January 15, 2018
    Report Date
    May 10, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237566894
    PMA / PMN Number
    K101207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS SELECTED AN IMPLANT DESIGN WHICH IS NOT RECOMMENDED FOR THE PATIENT'S BONE QUALITY. MOREOVER, IT WAS SEEN THAT THE DENTIST HAS USED LESS DRILLS THAN RECOMMENDED TO PERFORM THE IMPLANT INSTALLATION.

    Description of Event or Problem · 0

    RP 011901 - THE DENTIST REPORTED THAT AFTER 4 MONTHS DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 32NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE III.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345422 TI TITAMAX IMPLANT (4.1)3.75X9 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800172251 07898237566894

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention