BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CM ALVIM IMPL TI 4.3X10

    MDR report key: 7648205 · Received June 28, 2018

    Report

    Report Number
    3008261720-2018-02782
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    May 14, 2018
    Report Date
    June 28, 2018
    Manufacturer
    NEODENT JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568966
    PMA / PMN Number
    K101945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    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 ONE WEEK AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 29 THE IMPLANT HAD NOT ACHIEVED PRIMARY STABILITY. CLINICIAN REPORTS POOR BONE QUANTITY/QUALITY. 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 ONE WEEK AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 29 THE IMPLANT HAD NOT ACHIEVED PRIMARY STABILITY. CLINICIAN REPORTS POOR BONE QUANTITY/QUALITY. 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
    489371 CM ALVIM IMPL TI 4.3X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT JJGC S.A. 132443 07898237568966

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention