BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI TITAMAX IMPLANT (4.1)3.75X11

    MDR report key: 7009795 · Received November 8, 2017

    Report

    Report Number
    3008261720-2017-00128
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    May 6, 2014
    Report Date
    July 30, 2015
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237566900
    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 111127 - THE DENTIST HAD TO REMOVE THE DENTAL IMPLANT BECAUSE IT HAD NO PRIMARY STABILITY. PATIENT HAD INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE II).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789864 TI TITAMAX IMPLANT (4.1)3.75X11 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800072046 07898237566900

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention