BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 4.3X11.5

    MDR report key: 7523210 · Received May 17, 2018

    Report

    Report Number
    3008261720-2018-02263
    Event Type
    Injury
    Date Received
    May 17, 2018
    Date of Event
    September 9, 2017
    Report Date
    May 17, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568751
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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

    RP 011861 - THE DENTIST REPORTED THAT AFTER 2 MONTHS DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 4#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 45NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE III.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365456 CM DRIVE IMPLANT 4.3X11.5 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800170118I 07898237568751

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention