BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM TITAMAX IMPLANT 3.5X9

    MDR report key: 7012810 · Received November 9, 2017

    Report

    Report Number
    3008261720-2017-00477
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    May 5, 2015
    Report Date
    September 17, 2015
    Manufacturer
    NEODENT JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568676
    PMA / PMN Number
    K101945
    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 112383 THE DENTIST REPORTED THAT 1 YEARS AND 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #19 IT WAS VERIFIED ITS NON OSSEOINTEGRATION. FORTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED. THE PATIENT PRESENTED BONE TYPE III.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791806 CM TITAMAX IMPLANT 3.5X9 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT JJGC S.A. 800077697 07898237568676

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention