BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE ACQUA IMPL TI 4.3X16

    MDR report key: 7606498 · Received June 15, 2018

    Report

    Report Number
    3008261720-2018-02683
    Event Type
    Injury
    Date Received
    June 15, 2018
    Date of Event
    April 30, 2018
    Report Date
    June 15, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016540
    PMA / PMN Number
    K133592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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.

    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 NEARLY 6 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 13, THE IMPLANT DID NOT OBTAIN INTEGRATION IN TYPE II BONE. CLINICIAN REPORTS PAIN, BRUXISM AND SMOKING. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS. (B)(4).

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT NEARLY 6 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 13, THE IMPLANT DID NOT OBTAIN INTEGRATION IN TYPE II BONE. CLINICIAN REPORTS PAIN, BRUXISM AND SMOKING. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448474 CM DRIVE ACQUA IMPL TI 4.3X16 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 83987I 07899878016540

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention ABUTMENT PLACEMENT| ABUTMENT PLACEMENT| ABUTMENT PLACEMENT