BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 3.5X11.5

    MDR report key: 7499208 · Received May 9, 2018

    Report

    Report Number
    3008261720-2018-02106
    Event Type
    Injury
    Date Received
    May 9, 2018
    Date of Event
    March 25, 2018
    Report Date
    May 9, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569314
    PMA / PMN Number
    K123022
    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. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS USED MORE DRILLS THAN RECOMMENDED TO PERFORM THE IMPLANT INSTALLATION.

    Description of Event or Problem · 0

    RP 011811 - THE DENTIST REPORTED THAT AFTER 1 MONTH DENTAL IMPLANT WAS INSTALLED IN INTRAORAL PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 30NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE II AND IMMEDIATE IMPLANT PROCEDURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340337 CM DRIVE IMPLANT 3.5X11.5 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800334703I 07898237569314

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention