BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI TITAMAX EX IMPLANT (4.1)3.75X11 MM

    MDR report key: 8905740 · Received August 19, 2019

    Report

    Report Number
    3008261720-2019-04135
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    July 12, 2019
    Report Date
    August 19, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568355
    PMA / PMN Number
    K101207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM, VISUAL CONFERENCE OF THE PRODUCT RETURNED BY THE DENTIST AND THE EVALUATION OF RELEVANT PRODUCTION RECORDS.

    Description of Event or Problem · 1

    (B)(4). THE DENTIST REPORTED THAT HAD TO REMOVE THE DENTAL IMPLANT DURING ITS INSTALLATION SURGERY BECAUSE IT DID NOT ACHIEVE A GOOD PRIMARY STABILITY. MOREOVER, THE PATIENT PRESENTED BONE TYPE III.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701936 TI TITAMAX EX IMPLANT (4.1)3.75X11 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800329444 07898237568355

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention