BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CM DRIVE IMPLANT, TITANIUM, 3.5 X 13 MM

    MDR report key: 7631553 · Received June 22, 2018

    Report

    Report Number
    3008261720-2018-02744
    Event Type
    Malfunction
    Date Received
    June 22, 2018
    Date of Event
    April 16, 2018
    Report Date
    June 22, 2018
    Manufacturer
    NEODENT JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878023340
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT AFTER 3.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 13 IN THE MOUTH IMPLANT WAS REMOVED. TYPE III BONE WAS REPORTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT AFTER 3.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 13 IN THE MOUTH IMPLANT WAS REMOVED. TYPE III BONE WAS REPORTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472942 CM DRIVE IMPLANT, TITANIUM, 3.5 X 13 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT JJGC S.A. 800235584I 07899878023340

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention