BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE ACQUA IMPL TI 4.3X11.5

    MDR report key: 7173116 · Received January 8, 2018

    Report

    Report Number
    3008261720-2018-00103
    Event Type
    Injury
    Date Received
    January 8, 2018
    Date of Event
    December 11, 2017
    Report Date
    January 8, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016526
    PMA / PMN Number
    K133592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC

    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

    THE CLINICIAN REPORTS THE IMPLANT PLACED IN ADA SITE 3 FAILED UPON INSERTION DUE TO INADEQUATE BONE DENSITY AND AIR POCKETS. CLINICIAN NOTED MOBILITY AND BONE LOSS. THE IMPLANT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT PLACED IN ADA SITE 3 FAILED UPON INSERTION DUE TO INADEQUATE BONE DENSITY AND AIR POCKETS. CLINICIAN NOTED MOBILITY AND BONE LOSS. THE IMPLANT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15168 CM DRIVE ACQUA IMPL TI 4.3X11.5 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800237483I 07899878016526

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention