BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT, TITANIUM, 4.3X11.5 MM

    MDR report key: 7259060 · Received February 9, 2018

    Report

    Report Number
    3008261720-2018-00656
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    December 13, 2017
    Report Date
    February 9, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878023302
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTAL ASSISTANT

    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, JUST UNDER TWO MONTHS AFTER THE IMPLANT WAS PLACED IN SITE 14, AN OSSEOINTEGRATION FAILURE WAS OBSERVED. THE BONE QUALITY WAS DETERMINED TO BE TYPE II. IT WAS REPORTED THAT SMOKING AND BRUXISM COULD HAVE INFLUENCED THE PROBLEM THE PATIENT EXPERIENCED. SIXTY NCM OF TORQUE WAS APPLIED AT IMPLANT PLACEMENT.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT, JUST UNDER TWO MONTHS AFTER THE IMPLANT WAS PLACED IN SITE 14, AN OSSEOINTEGRATION FAILURE WAS OBSERVED. THE BONE QUALITY WAS DETERMINED TO BE TYPE II. IT WAS REPORTED THAT SMOKING AND BRUXISM COULD HAVE INFLUENCED THE PROBLEM THE PATIENT EXPERIENCED. 60 NCM OF TORQUE WAS APPLIED AT IMPLANT PLACEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104809 CM DRIVE IMPLANT, TITANIUM, 4.3X11.5 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800235331I 07899878023302

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention