BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WS TITAMAX IMPLANT 4.0X6

    MDR report key: 7498011 · Received May 9, 2018

    Report

    Report Number
    3008261720-2018-02077
    Event Type
    Injury
    Date Received
    May 9, 2018
    Date of Event
    December 21, 2017
    Report Date
    May 9, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568577
    PMA / PMN Number
    K123022
    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 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 011700 - THE DENTIST REPORTED THAT AFTER 1 MONTH DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 19#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED BONE TYPE I.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341970 WS TITAMAX IMPLANT 4.0X6 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 48433 07898237568577

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention