BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI TITAMAX IMPLANT (4.1)3.75X13

    MDR report key: 7478968 · Received May 2, 2018

    Report

    Report Number
    3008261720-2018-01938
    Event Type
    Injury
    Date Received
    May 2, 2018
    Date of Event
    March 1, 2018
    Report Date
    May 2, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237566917
    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 REPORT ON BEHALF OF NEODENT - JJGC. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS USED SEQUENCE OF DRILLS DIFFERENT THAN THE ONES RECOMMENDED FOR THE IMPLANT INSTALLATION.

    Description of Event or Problem · 0

    RP 011498 - THE DENTIST REPORTED THAT AFTER NEARLY 1 MONTH DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 19#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED BONE TYPE I AND 45NCM OF PRIMARY STABILITY WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323179 TI TITAMAX IMPLANT (4.1)3.75X13 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800321866 07898237566917

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention