BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI TITAMAX IMPLANT (4.1)3.75X9 MM

    MDR report key: 8921720 · Received August 22, 2019

    Report

    Report Number
    3008261720-2019-04183
    Event Type
    Injury
    Date Received
    August 22, 2019
    Date of Event
    July 5, 2019
    Report Date
    August 22, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237566894
    PMA / PMN Number
    K101207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION WAS NOTICED THAT THE LOT NUMBER INFORMED DOES NOT CORRESPOND TO THE ITEM RECEIVED. THEREFORE, THE LOT NUMBER WAS NOT CONSIDERED. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS USED SEQUENCE OF DRILLS DIFFERENT THAN THE ONE RECOMMENDED FOR THE IMPLANT INSTALLATION. THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM AND VISUAL CONFERENCE OF THE PRODUCT RETURNED BY THE DENTIST.

    Description of Event or Problem · 1

    (B)(4). THE DENTIST REPORTED THAT 1 MONTH AND 15 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 12N.CM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716574 TI TITAMAX IMPLANT (4.1)3.75X9 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 07898237566894

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention