BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM ALVIM IMPLANT 5.0X8 MM

    MDR report key: 7940204 · Received October 5, 2018

    Report

    Report Number
    3008261720-2018-04927
    Event Type
    Injury
    Date Received
    October 5, 2018
    Date of Event
    April 13, 2018
    Report Date
    October 5, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568997
    PMA / PMN Number
    K101945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    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

    (B)(4). THE DENTIST REPORTED THAT THE DENTIST HAD TO REMOVE THE DENTAL IMPLANT DURING ITS INSTALLATION SURGERY DUE TO THE FRACTURE OF ABUTMENT. THE DENTIST ALSO INFORMED THAT IMMEDIATE IMPLANT PROCEDURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780935 CM ALVIM IMPLANT 5.0X8 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800323991 07898237568997

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention