BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WS TITAMAX IMPLANT 4.0X5

    MDR report key: 7498027 · Received May 9, 2018

    Report

    Report Number
    3008261720-2018-02096
    Event Type
    Injury
    Date Received
    May 9, 2018
    Date of Event
    January 1, 2018
    Report Date
    May 9, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    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. THE DEVICE DOES NOT HAVE A 510 (K) BUT WAS ONCE IMPROPERLY SOLD IN US AND IS BEING REPORTED SINCE THERE STILL ARE 2 UNITS INSTALLED IN PATIENTS. IN TELEPHONE CONTACT, THE DENTIST INFORMED THAT HE DID NOT HAVE INFORMATION ABOUT LOT NUMBER OF THE PRODUCT. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS USED SEQUENCE OF DRILLS DIFFERENT THAN THE ONES RECOMMENDED FOR THE IMPLANT INSTALLATION.

    Description of Event or Problem · 0

    RP 011785 - THE DENTIST REPORTED THAT AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340796 WS TITAMAX IMPLANT 4.0X5 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention