BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM TITAMAX IMPLANT 3.75X7

    MDR report key: 7663358 · Received July 5, 2018

    Report

    Report Number
    3008261720-2018-02971
    Event Type
    Injury
    Date Received
    July 5, 2018
    Date of Event
    February 20, 2018
    Report Date
    July 5, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568584
    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. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS USED LESS DRILLS THAN RECOMMENDED TO PERFORM THE IMPLANT INSTALLATION.

    Description of Event or Problem · 0

    RP.012656¿ THE DENTIST REPORTED THAT 1 MONTH AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE II) AND 32 NCM OF PRIMARY STABILITY WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506264 CM TITAMAX IMPLANT 3.75X7 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800080178 07898237568584

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention