BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI TITAMAX IMPLANT (4.1) 3.75X11

    MDR report key: 4747691 · Received April 30, 2015

    Report

    Report Number
    3010593814-2015-00188
    Event Type
    Malfunction
    Date Received
    April 30, 2015
    Date of Event
    January 1, 2014
    Report Date
    September 30, 2014
    Product Code
    DZE
    PMA / PMN Number
    K133510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE PT WAS SUBMITTED OT A SURGERY TO INSTALL 4 DENTAL IMPLANTS, BUT ONE OF THEM DID NOT OSSEOINTEGRATED. THE DENTIST DID NOT PROVIDE FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286102 TI TITAMAX IMPLANT (4.1) 3.75X11 ENDOSSEOUS DENTAL IMPLANT DZE NA 800103407

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention