BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE ACQUA IMPLANT 4.3X10 MM

    MDR report key: 8921715 · Received August 22, 2019

    Report

    Report Number
    3008261720-2019-04188
    Event Type
    Injury
    Date Received
    August 22, 2019
    Date of Event
    June 6, 2019
    Report Date
    August 22, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016892
    PMA / PMN Number
    K133592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE INFORMATION PROVIDED IN THIS REPORT WAS BASED ON INFORMATION GIVEN BY THE DENTIST IN NEODENT¿S PRODUCTS WARRANTY FORM. THE ORIGINAL COMPLAINT WAS RECEIVED BY THE SUBSIDIARY AND DID NOT ARRIVE IN THE MANUFACTURER YET. WHEN THIS HAPPENS, A NEW EVALUATION OF THE COMPLAINT WILL BE CARRIED OUT AND, IF NECESSARY, A FOLLOW-UP REPORT WILL BE SEND.

    Description of Event or Problem · 1

    (B)(4) - THE DENTIST REPORTED THAT 4 MONTHS AND 13 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 14#, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED BONE TYPE II AND BONE GRAFT WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716287 CM DRIVE ACQUA IMPLANT 4.3X10 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800341833 07899878016892

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention