BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI TITAMAX IMPLANT (4.1)3.75X13

    MDR report key: 7400988 · Received April 5, 2018

    Report

    Report Number
    3008261720-2018-01578
    Event Type
    Injury
    Date Received
    April 5, 2018
    Date of Event
    March 6, 2018
    Report Date
    April 9, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237566917
    PMA / PMN Number
    K101207
    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. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS SELECTED AN IMPLANT DESIGN WHICH IS NOT RECOMMENDED FOR THE PATIENT'S BONE QUALITY.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. THE DENTIST SENT NEW INFORMATION ABOUT THE EVENT. THUS, THE EVENT EVALUATION WAS MODIFIED ACCORDING TO THE NEW INFORMATION RECEIVED. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS USED LESS DRILLS THAN RECOMMENDED TO PERFORM THE IMPLANT INSTALLATION.

    Description of Event or Problem · 0

    (B)(4). THE DENTIST REPORTED THAT 3 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PROCEDURES OF IMMEDIATE LOAD WAS PERFORMED AND FENESTRATION OCCURRED DURING SURGERY.

    Description of Event or Problem · 0

    (B)(4). THE DENTIST REPORTED THAT 3 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PROCEDURES OF IMMEDIATE LOAD WAS PERFORMED AND FENESTRATION OCCURRED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243903 TI TITAMAX IMPLANT (4.1)3.75X13 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 120723 07898237566917

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention