BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM TITAMAX IMPLANT 3.5X11

    MDR report key: 7011056 · Received November 8, 2017

    Report

    Report Number
    3008261720-2017-00203
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    June 10, 2015
    Report Date
    August 5, 2015
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568683
    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.

    Description of Event or Problem · 0

    OS 111334 - THE DENTIST REPORTED THAT THE PATIENT PRESENTED PAIN POST-SURGERY AND 2 DAYS AFTER THE INSTALLATION OF THE DENTAL IMPLANT. SIXTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND PATIENT PRESENTED BONE TYPE II. BONE OVERHEATING HAPPENED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791027 CM TITAMAX IMPLANT 3.5X11 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 07898237568683

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention