BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM TITAMAX EX ACQUA IMPLANT 3.75X11 MM

    MDR report key: 7829375 · Received August 29, 2018

    Report

    Report Number
    3008261720-2018-03622
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    June 20, 2018
    Report Date
    August 29, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016793
    PMA / PMN Number
    K133592
    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. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS USED MORE DRILLS THAN RECOMMENDED TO PERFORM THE IMPLANT INSTALLATION.

    Description of Event or Problem · 0

    RP.013326 ¿ THE DENTIST REPORTED THAT 3 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THIRTY-TWO NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE III AND IMMEDIATE IMPLANT PROCEDURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668232 CM TITAMAX EX ACQUA IMPLANT 3.75X11 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 66792 07899878016793

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention