BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI TITAMAX IMPLANT (4.1)3.75X9

    MDR report key: 7663349 · Received July 5, 2018

    Report

    Report Number
    3008261720-2018-02959
    Event Type
    Injury
    Date Received
    July 5, 2018
    Date of Event
    April 27, 2018
    Report Date
    July 5, 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 · 1

    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 LESS DRILLS THAN RECOMMENDED TO PERFORM THE IMPLANT INSTALLATION. MOREOVER, THE DENTIST REPORTED THAT THE IMPLANT WAS IMMEDIATELY INSTALLED IN AN ALVEOLUS WITH SIGNS OF INJURY/ INFECTION.

    Description of Event or Problem · 1

    RP.012635¿ THE DENTIST REPORTED THAT 7 DAYS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 18#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE II), FENESTRATION OCCURRED DURING SURGERY AND IMMEDIATE IMPLANT AND IMMEDIATE LOAD WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506127 TI TITAMAX IMPLANT (4.1)3.75X9 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 128206 07898237566894

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention