BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT, TITANIUM, 4.3X11.5 MM

    MDR report key: 7259063 · Received February 9, 2018

    Report

    Report Number
    3008261720-2018-00657
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    January 2, 2018
    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. AFTER THE EVALUATION, THE EVENT WAS CONSIDERED AS LOSS OF OSSEOINTEGRATION.

    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, JUST OVER EIGHT MONTHS AFTER THE IMPLANT WAS PLACED IN SITE 14, A LOSS OF OSSEOINTEGRATION WAS OBSERVED. THE BONE QUALITY WAS DETERMINED TO BE TYPE III. IT WAS REPORTED THAT SMOKING AND BRUXISM COULD HAVE INFLUENCED THE PROBLEM. IN ADDITION, 60 NCM OF TORQUE WAS APPLIED AT IMPLANT PLACEMENT. (B)(4).

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT, JUST OVER EIGHT MONTHS AFTER THE IMPLANT WAS PLACED IN SITE 14, A LOSS OF OSSEOINTEGRATION WAS OBSERVED. THE BONE QUALITY WAS DETERMINED TO BE TYPE III. IT WAS REPORTED THAT SMOKING AND BRUXISM COULD HAVE INFLUENCED THE PROBLEM. SIXTY (60) NCM OF TORQUE WAS APPLIED AT IMPLANT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103336 CM DRIVE IMPLANT, TITANIUM, 4.3X11.5 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800236346I 07899878023302

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention ABUTMENT| ABUTMENT| ABUTMENT