BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM ALVIM IMPLANT 3.5X13

    MDR report key: 7483151 · Received May 3, 2018

    Report

    Report Number
    3008261720-2018-02015
    Event Type
    Injury
    Date Received
    May 3, 2018
    Date of Event
    March 20, 2018
    Report Date
    May 3, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568737
    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 REPORTON BEHALF OF NEODENT - JJGC. AFTER THE EVALUATION WAS NOTICED THAT THEITEM RECEIVED IS DIFFERENT FROM THE ITEM REPORTED ON GUARANTEE FORM BYTHE DENTIST. THEREFORE, THE LOT NUMBER WAS NOT CONSIDERED.

    Description of Event or Problem · 0

    RP 011599- THE DENTIST REPORTED THAT AFTER 6 MONTHS DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 7#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 15NCM OF PRIMARY STABILITY WAS ACHIEVED, IMMEDIATE IMPLANT PROCEDURE WAS DONE, BONE GRAFT WAS EXECUTED, FENESTRATION OCCURRED DURING SURGERY AND THE PATIENT PRESENTED BONE TYPE IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327652 CM ALVIM IMPLANT 3.5X13 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 07898237568737

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention