BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM TITAMAX EX ACQUA IMPLANT 4.0X11

    MDR report key: 8250637 · Received January 15, 2019

    Report

    Report Number
    3008261720-2019-00281
    Event Type
    Injury
    Date Received
    January 15, 2019
    Date of Event
    August 16, 2018
    Report Date
    February 8, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016564
    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. 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 INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM, VISUAL CONFERENCE OF THE PRODUCT RETURNED BY THE DENTIST AND THE EVALUATION OF RELEVANT PRODUCTION RECORDS.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC.

    Additional Manufacturer Narrative · 0

    THE PLACEMENT/REMOVAL DATES OF THE IMPLANT WERE REQUESTED FROM THE INITIAL REPORTER. THE BEST ESTIMATE OF THE DATE OF EVENT WAS PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INFORMATION BECOMES AVAILABLE. 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 6.5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 10 IN THE MOUTH, THE IMPLANT LOST INTEGRATION IN TYPE I BONE. THE IMPLANT WAS TORQUED MANUALLY TO 50 NCM. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS. (B)(4).

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT AFTER 6.5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 10 IN THE MOUTH, THE IMPLANT LOST INTEGRATION IN TYPE I BONE. THE IMPLANT WAS TORQUED MANUALLY TO 50 NCM. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 10 IN THE MOUTH, THE IMPLANT FAILED IN TYPE I BONE. THE IMPLANT WAS TORQUED MANUALLY TO 50 NCM. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42563 CM TITAMAX EX ACQUA IMPLANT 4.0X11 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800309025 07899878016564

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention