BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI TITAMAX EX IMPLANT (4.1)4.0X13

    MDR report key: 7010857 · Received November 8, 2017

    Report

    Report Number
    3008261720-2017-00185
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    January 1, 2015
    Report Date
    August 4, 2015
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568423
    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 111291 - IT WAS VERIFIED THE FAILURE OF THE OSSEOINTEGRATION OF A DENTAL IMPLANT. 20 NCM OF PRIMARY STABILITY WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790286 TI TITAMAX EX IMPLANT (4.1)4.0X13 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 07898237568423

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention