BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE ACQUA IMPLANT 4.3X11.5

    MDR report key: 7852404 · Received September 6, 2018

    Report

    Report Number
    3008261720-2018-04471
    Event Type
    Injury
    Date Received
    September 6, 2018
    Date of Event
    May 20, 2018
    Report Date
    September 6, 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
    CO, 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. 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. THE DENTIST REPORTED THAT IMMEDIATE LOAD PROCEDURE WAS PERFORMED.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THAT 14 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 4 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE II BONE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THAT 14 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 4 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE II BONE. THE PRODUCT 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
    694852 CM DRIVE ACQUA IMPLANT 4.3X11.5 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 83015I 07899878016526

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention