BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI TITAMAX IMPLANT (4.1)4.0X13

    MDR report key: 7011079 · Received November 8, 2017

    Report

    Report Number
    3008261720-2017-00234
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    July 27, 2015
    Report Date
    August 12, 2015
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237567013
    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 111487 - THE DENTIST REPORTED THAT FOUR DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #25 IT WAS VERIFIED ITS NON- OSSEOINTEGRATION . FORTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED. PATIENT PRESENTED BONE TYPE III.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788451 TI TITAMAX IMPLANT (4.1)4.0X13 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800128222 07898237567013

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention