BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM ALVIM ACQUA IMPLANT 4.3X13

    MDR report key: 7346917 · Received March 16, 2018

    Report

    Report Number
    3008261720-2018-01225
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    October 3, 2017
    Report Date
    March 16, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016519
    PMA / PMN Number
    K150199
    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

    RP 010835 ¿ THE DENTIST REPORTED THAT 1 YEAR AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #8, ITS NON-OSSEOINTEGRATION WAS OBSERVED. FIFTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PROCEDURE OF IMMEDIATE LOAD WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188710 CM ALVIM ACQUA IMPLANT 4.3X13 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800155378 07899878016519

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention