BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM ALVIM IMPLANT 4.3X11.5

    MDR report key: 7012847 · Received November 9, 2017

    Report

    Report Number
    3008261720-2017-00527
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    September 10, 2014
    Report Date
    September 24, 2015
    Manufacturer
    NEODENT JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568973
    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 112591. THE DENTIST REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #28, IT WAS VERIFIED ITS LOSS OF OSSEOINTEGRATION. FORTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED. THE PATIENT PRESENTED BONE TYPE I.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792112 CM ALVIM IMPLANT 4.3X11.5 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT JJGC S.A. 07898237568973

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention