BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM TITAMAX EX IMPLANT 4.0X11 MM

    MDR report key: 8441462 · Received March 21, 2019

    Report

    Report Number
    3008261720-2019-01236
    Event Type
    Injury
    Date Received
    March 21, 2019
    Date of Event
    January 1, 2019
    Report Date
    March 21, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568850
    PMA / PMN Number
    K101945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. FOLLOW UP BEING SENT TO JUSTIFY THE ABSENCE OF THE LOT NUMBER. IN TELEPHONE CONTACT, IT WAS INFORMED THAT THE DENTIST DID NOT HAVE INFORMATION ABOUT LOT NUMBER OF THE PRODUCT. THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM AND VISUAL CONFERENCE OF THE PRODUCT RETURNED BY THE DENTIST.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM AND VISUAL CONFERENCE OF THE PRODUCT RETURNED BY THE DENTIST.

    Description of Event or Problem · 0

    (B)(4). THE DENTIST REPORTED THAT AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 5#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 45N.CM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY.

    Description of Event or Problem · 0

    (B)(4). THE DENTIST REPORTED THAT AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #5, ITS NON-OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 45N.CM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234357 CM TITAMAX EX IMPLANT 4.0X11 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 07898237568850

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention