BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM TITAMAX IMPLANT 4.0X7

    MDR report key: 7430750 · Received April 13, 2018

    Report

    Report Number
    3008261720-2018-01712
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    February 12, 2018
    Report Date
    April 13, 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
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. IN TELEPHONE CONTACT, THE DENTIST INFORMED THAT HE DID NOT HAVE INFORMATION ABOUT LOT NUMBER OF THE PRODUCT.

    Description of Event or Problem · 0

    RP 011131 - THE DENTIST REPORTED THAT 5 YEARS AND 5 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED BONE TYPE III AND PERI- IMPLANTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270772 CM TITAMAX IMPLANT 4.0X7 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 07898237568782

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention