BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM TITAMAX EX ACQUA IMPLANT 3.5X13

    MDR report key: 8714270 · Received June 19, 2019

    Report

    Report Number
    3008261720-2019-02751
    Event Type
    Injury
    Date Received
    June 19, 2019
    Date of Event
    May 17, 2019
    Report Date
    June 19, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016755
    PMA / PMN Number
    K133592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLINICIAN PLACED AN EXPIRED IMPLANT. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. THE INFORMATION PROVIDED IN THIS REPORT WAS BASED ON INFORMATION GIVEN BY THE DENTIST IN NEODENT¿S PRODUCTS WARRANTY FORM THAT WAS RECORDED IN THE SYSTEM THAT IS USED BY BOTH THE MANUFACTURER AND THE SUBSIDIARY. THE ORIGINAL COMPLAINT AND THE PRODUCT WERE 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 NEW FOLLOW-UP REPORT WILL BE SEND.

    Additional Manufacturer Narrative · 0

    THE CLINICIAN PLACED AN EXPIRED IMPLANT. 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 1 MONTH AFTER THE DENTAL IMPLANT WAS PLACED IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. THE CLINICIAN NOTED PAIN AND IMPLANT MOBILITY IN THIS PATIENT WITH EXCELLENT HYGIENE. 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 1 MONTH AFTER THE DENTAL IMPLANT WAS PLACED IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. THE CLINICIAN NOTED PAIN AND IMPLANT MOBILITY IN THIS PATIENT WITH EXCELLENT HYGIENE. 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
    506669 CM TITAMAX EX ACQUA IMPLANT 3.5X13 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800171688 07899878016755

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention