BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT, TITANIUM, 4.3X8 MM

    MDR report key: 7824284 · Received August 28, 2018

    Report

    Report Number
    3008261720-2018-03096
    Event Type
    Injury
    Date Received
    August 28, 2018
    Date of Event
    June 7, 2018
    Report Date
    August 28, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878023401
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 4 IN THE MOUTH, IT HAD NOT YET ACHIEVED INTEGRATION IN TYPE II BONE. CLINICIAN REPORTS PERI-IMPLANTITIS AND PAIN. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 4 IN THE MOUTH, IT HAD NOT YET ACHIEVED INTEGRATION IN TYPE II BONE. CLINICIAN REPORTS PERI-IMPLANTITIS AND PAIN. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662683 CM DRIVE IMPLANT, TITANIUM, 4.3X8 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800324046I 07899878023401

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention