BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM TITAMAX IMPLANT 4.0X7

    MDR report key: 7401028 · Received April 5, 2018

    Report

    Report Number
    3008261720-2018-01634
    Event Type
    Injury
    Date Received
    April 5, 2018
    Date of Event
    November 29, 2017
    Report Date
    April 5, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568782
    PMA / PMN Number
    K101945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORTON BEHALF OF NEODENT - JJGC. CONSIDERING THE SURGICAL METHODOLOGY, ITWAS SEEN THAT THE DENTIST HAS USED SEQUENCE OF DRILLS DIFFERENT THAN THEONES RECOMMENDED FOR THE IMPLANT INSTALLATION.

    Description of Event or Problem · 0

    RP 011097 - THE DENTIST REPORTED THAT 3 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED BONE TYPE II, IMMEDIATE LOAD AND IMMEDIATE IMPLANT WERE PERFORMED AND 50NCM OF PRIMARY STABILITY WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241871 CM TITAMAX IMPLANT 4.0X7 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800238105 07898237568782

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention