BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT, TITANIUM, 5.0X8 MM

    MDR report key: 7830365 · Received August 29, 2018

    Report

    Report Number
    3008261720-2018-03930
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    March 1, 2018
    Report Date
    August 29, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878023418
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 NEARLY 1 MONTH AFTER THE DENTAL IMPLANT WAS PLACED IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE INTEGRATION IN TYPE I BONE. CLINICIAN REPORTS BONE LOSS AND POOR BONE QUALITY/QUANTITY. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT NEARLY 1 MONTH AFTER THE DENTAL IMPLANT WAS PLACED IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE INTEGRATION IN TYPE I BONE. CLINICIAN REPORTS BONE LOSS AND POOR BONE QUALITY/QUANTITY. 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
    670459 CM DRIVE IMPLANT, TITANIUM, 5.0X8 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 121505I 07899878023418

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention GRAFT| GRAFT