BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT, TITANIUM, 5.0X11.5 MM

    MDR report key: 7830327 · Received August 29, 2018

    Report

    Report Number
    3008261720-2018-03888
    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
    07899878023425
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    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

    ON THE DAY THE IMPLANT WAS PLACED IN THE MOUTH, THE CLINICIAN REPORTS THAT THE BONE DEFECT AT THE SITE PROVED TOO LARGE TO ACHIEVE PRIMARY STABILITY IN TYPE II BONE. ANOTHER IMPLANT WAS NOT PLACED IN THE SAME SITE ON THE SAME DAY. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: E2015015. (B)(4). 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 · 1

    ON THE DAY THE IMPLANT WAS PLACED IN THE MOUTH, THE CLINICIAN REPORTS THAT THE BONE DEFECT AT THE SITE PROVED TOO LARGE TO ACHIEVE PRIMARY STABILITY IN TYPE II BONE. ANOTHER IMPLANT WAS NOT PLACED IN THE SAME SITE ON THE SAME DAY. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670446 CM DRIVE IMPLANT, TITANIUM, 5.0X11.5 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 85201I 07899878023425

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention GRAFT| GRAFT