BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE ACQUA IMPL TI 4.3X8

    MDR report key: 7830322 · Received August 29, 2018

    Report

    Report Number
    3008261720-2018-03890
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    February 26, 2018
    Report Date
    August 29, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016908
    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.

    Description of Event or Problem · 0

    ON THE DAY THE IMPLANT WAS PLACED IN ADA SITE 13 IN THE MOUTH, PRIMARY STABILITY WAS NOT ACHIEVED IN TYPE I 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 ADA SITE 13 IN THE MOUTH, PRIMARY STABILITY WAS NOT ACHIEVED IN TYPE I 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
    670202 CM DRIVE ACQUA IMPL TI 4.3X8 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 69844I 07899878016908

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention GRAFT| GRAFT