BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE ACQUA IMPL TI 3.5X13

    MDR report key: 7848586 · Received September 5, 2018

    Report

    Report Number
    3008261720-2018-04461
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    August 2, 2018
    Report Date
    September 5, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016847
    PMA / PMN Number
    K133592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 1.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 7 IN THE MOUTH, THE IMPLANT HAD NOT INTEGRATED IN TYPE II BONE. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 1.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 7 IN THE MOUTH, THE IMPLANT HAD NOT INTEGRATED IN TYPE II BONE. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686288 CM DRIVE ACQUA IMPL TI 3.5X13 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800331324I 07899878016847

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GRAFT| GRAFT