BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI TITAMAX EX IMPLANT (4.1)4.0X11

    MDR report key: 7346824 · Received March 16, 2018

    Report

    Report Number
    3008261720-2018-01250
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    December 21, 2017
    Report Date
    March 16, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568416
    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

    RP 010841 ¿ THE DENTIST REPORTED THAT 1 MONTH AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #13, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED BONE TYPE IV, THE PROCEDURE OF IMMEDIATE LOAD WAS PERFORMED AND BONE GRAFT WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188144 TI TITAMAX EX IMPLANT (4.1)4.0X11 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800303335 07898237568416

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention