BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT, TITANIUM, 4.3X11.5 MM

    MDR report key: 7830328 · Received August 29, 2018

    Report

    Report Number
    3008261720-2018-03936
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    July 9, 2018
    Report Date
    August 29, 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
    NJ, 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 2.5 WEEKS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 3 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE INTEGRATION IN TYPE II BONE. CLINICIAN REPORTS PAIN AND MOBILITY. THE SITE WAS GRAFTED. 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 2.5 WEEKS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 3 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE INTEGRATION IN TYPE II BONE. CLINICIAN REPORTS PAIN AND MOBILITY. THE SITE WAS GRAFTED. 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
    670449 CM DRIVE IMPLANT, TITANIUM, 4.3X11.5 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800234882I 07899878023302

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention GRAFT| GRAFT