BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM ALVIM IMPLANT 4.3X10

    MDR report key: 7498028 · Received May 9, 2018

    Report

    Report Number
    3008261720-2018-02083
    Event Type
    Injury
    Date Received
    May 9, 2018
    Date of Event
    September 18, 2017
    Report Date
    May 9, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568966
    PMA / PMN Number
    K101945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. AFTER THE EVALUATION WAS NOTICED THAT THE ITEM RECEIVED IS DIFFERENT FROM THE ITEM REPORTED ON GUARANTEE FORM BY THE DENTIST. THEREFORE, THE LOT NUMBER WAS NOT CONSIDERED. 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 011719 - THE DENTIST REPORTED THAT AFTER NEARLY 3 MONTHS DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 28#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 40NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340797 CM ALVIM IMPLANT 4.3X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 07898237568966

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention