BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 4.3X8

    MDR report key: 7028889 · Received November 14, 2017

    Report

    Report Number
    3008261720-2017-04819
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    August 17, 2017
    Report Date
    November 14, 2017
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569314
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. AFTER THE EVALUATION PERFORMED BY THE MANUFACTURER, IT WAS NOTICED THAT THE ITEM RECIEVED IS DIFERENT FROM THE ITEM FIRST REPORTED.

    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 REPORTED THAT 11 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN SITE ADA #20 OF PATIENT'S MOUTH, A LOSS OF OSSEOINTEGRATION WAS OBSERVED. THE PATIENT'S BONE QUALITY WAS REPORTED TO BE TYPE II. THE CLINICIAN REPORTED OCCLUSAL TRAUMA, BIOMECHANICAL OVERLOAD, IMMEDIATE LOAD AND PERIMPLANTITIS TO HAVE INFLUENCED THE PROBLEM. THIS DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 11 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN SITE ADA #20 OF PATIENT'S MOUTH, A LOSS OF OSSEOINTEGRATION WAS OBSERVED. THE PATIENT'S BONE QUALITY WAS REPORTED TO BE TYPE II. THE CLINICIAN REPORTED OCCUSAL TRAUMA, BIOMECHANICAL OVERLOAD, IMMEDIATE LOAD AND PERIMPLANTITIS TO HAVE INFLUENCED THE PROBLEM. THIS DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807068 CM DRIVE IMPLANT 4.3X8 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 32657I 07898237569314

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention