BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI TITAMAX EX IMPLANT (4.1)3.75X15

    MDR report key: 7012706 · Received November 9, 2017

    Report

    Report Number
    3008261720-2017-00348
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    July 16, 2015
    Report Date
    August 31, 2015
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568379
    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.

    Description of Event or Problem · 0

    OS 111916 - THE DENTIST REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #13 IT WAS VERIFIED ITS NON- OSSEOINTEGRATION . TWENTY-FIVE NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT EXECUTED. THE PATIENT PRESENTED BONE TYPE III.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793914 TI TITAMAX EX IMPLANT (4.1)3.75X15 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800171850 07898237568379

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention