BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM ALVIM ACQUA IMPLANT 3.5X10

    MDR report key: 7598752 · Received June 13, 2018

    Report

    Report Number
    3008261720-2018-02632
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    May 10, 2018
    Report Date
    June 13, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016700
    PMA / PMN Number
    K150199
    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 SELECTED AN IMPLANT DESIGN WHICH IS NOT RECOMMENDED FOR THE PATIENT'S BONE QUALITY.

    Description of Event or Problem · 0

    RP 012322 - THE DENTIST REPORTED THAT 3 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 12#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 60NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438776 CM ALVIM ACQUA IMPLANT 3.5X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 121597 07899878016700

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention