BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI TITAMAX EX IMPANT (4.1) 3.75X9

    MDR report key: 4747576 · Received April 30, 2015

    Report

    Report Number
    3010593814-2015-00078
    Event Type
    Malfunction
    Date Received
    April 30, 2015
    Date of Event
    January 1, 2014
    Report Date
    September 10, 2014
    Product Code
    DZE
    PMA / PMN Number
    K101207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DENTIST REPORTED THAT AFTER 1 MONTH THAT THE DENTAL IMPLANT WAS INSTALLED IN INTRA-ORAL REGION #29 (ADA SYSTEM) OF THE PATIENT, IT WAS VERIFIED ITS NON-OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286357 TI TITAMAX EX IMPANT (4.1) 3.75X9 ENDOSSEOUS DENTAL IMPLANT DZE NA 800080803

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention