BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM TITAMAX IMPL TI 4.0X7

    MDR report key: 7097455 · Received December 7, 2017

    Report

    Report Number
    3008261720-2017-06682
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    July 26, 2017
    Report Date
    December 7, 2017
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568782
    PMA / PMN Number
    K101945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORTON BEHALF OF NEODENT - JJGC

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT, 4 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN THE PATIENT'S MOUTH, NON-OSSEOINTEGRATION WAS OBSERVED. FIFTEEN (15) NCM OF PRIMARY STABILITY WAS ACHIEVED. THE CLINICIAN REPORTED THAT THE PATIENT EXPERIENCED PAIN FOLLOWING THE EVENT. IT WAS ALSO NOTED THAT SMOKING COULD HAVE INFLUENCED THE PROBLEM FOUND.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT, 4 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN THE PATIENT'S MOUTH, NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 15 NCM OF PRIMARY STABILITY WAS ACHIEVED. THE CLINICIAN REPORTED THAT THE PATIENT EXPERIENCED PAIN FOLLOWING THE EVENT. IT WAS ALSO NOTED THAT SMOKING COULD HAVE INFLUENCED THE PROBLEM FOUND. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875175 CM TITAMAX IMPL TI 4.0X7 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 64435 07898237568782

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention