BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI TITAMAX IMPLANT (4.1)4.0X11

    MDR report key: 7479021 · Received May 2, 2018

    Report

    Report Number
    3008261720-2018-01986
    Event Type
    Injury
    Date Received
    May 2, 2018
    Date of Event
    March 17, 2018
    Report Date
    May 2, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237567006
    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. INSTRADENT USA, INC IS SUBMITTING THE REPORTON BEHALF OF NEODENT - JJGC.

    Description of Event or Problem · 0

    RP 011596- THE DENTIST REPORTED THAT AFTER 10 YEARS DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 19#, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, BONE GRAFT WAS EXECUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323338 TI TITAMAX IMPLANT (4.1)4.0X11 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 07898237567006

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention