BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI TITAMAX IMPLANT (4.1)3.75X9 MM

    MDR report key: 7830155 · Received August 29, 2018

    Report

    Report Number
    3008261720-2018-04320
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    January 1, 2018
    Report Date
    August 29, 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 · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. AFTER THE EVALUATION WAS NOTICED THAT THE LOT NUMBER REPORTED IS NOT FROM THE ITEM RECEIVED. THEREFORE, THE LOT NUMBER WAS NOT CONSIDERED. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS SELECTED AN IMPLANT DESIGN WHICH IS NOT RECOMMENDED FOR THE PATIENT'S BONE QUALITY.

    Description of Event or Problem · 0

    RP.013984 ¿ THE DENTIST REPORTED THAT AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 19#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED POOR BONE QUALITY/QUANTITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670158 TI TITAMAX IMPLANT (4.1)3.75X9 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 07898237566894

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention