BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE ACQUA IMPLANT 4.3X13

    MDR report key: 7533098 · Received May 22, 2018

    Report

    Report Number
    3008261720-2018-02307
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    March 25, 2018
    Report Date
    May 22, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016533
    PMA / PMN Number
    K133592
    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.

    Description of Event or Problem · 0

    RP 011978 - THE DENTIST REPORTED THAT 1 MONTH AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 8#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 45NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE II AND IMMEDIATE IMPLANT WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377872 CM DRIVE ACQUA IMPLANT 4.3X13 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800237819I 07899878016533

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention