BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM TITAMAX EX IMPLANT 3.75X15

    MDR report key: 7011078 · Received November 8, 2017

    Report

    Report Number
    3008261720-2017-00239
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    April 27, 2015
    Report Date
    August 13, 2015
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569161
    PMA / PMN Number
    K101945
    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 111501 - THE DENTIST REPORTED THAT 23 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #7 IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. IMPLANT WAS IMMEDIATELY CARRIED OUT, 35 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS PERFORMED. PATIENT PRESENTED BONE TYPE III.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788450 CM TITAMAX EX IMPLANT 3.75X15 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800086141 07898237569161

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention