BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT, TITANIUM, 4.3X11.5 MM

    MDR report key: 7259052 · Received February 9, 2018

    Report

    Report Number
    3008261720-2018-00655
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    November 7, 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

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT, JUST OVER FOUR MONTHS AFTER IMPLANT PLACEMENT, NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT EXPERIENCED PAIN AFTER THE EVENT. IT WAS NOTED THAT SMOKING AND BRUXISM COULD HAVE INFLUENCED THE PROBLEM FOUND. FORTY-FIVE (45) NCM OF TORQUE WAS APPLIED DURING IMPLANT PLACEMENT.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT, JUST OVER FOUR MONTHS AFTER IMPLANT PLACEMENT, NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT EXPERIENCED PAIN AFTER THE EVENT. IT WAS NOTED THAT SMOKING AND BRUXISM COULD HAVE INFLUENCED THE PROBLEM FOUND. IN ADDITION, 45 NCM OF TORQUE WAS APPLIED DURING IMPLANT PLACEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105438 CM DRIVE IMPLANT, TITANIUM, 4.3X11.5 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 86912I 07899878023302

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention ABUTMENT| ABUTMENT| ABUTMENT