BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CM TITAMAX IMPL TI 4.0X9

    MDR report key: 7631548 · Received June 22, 2018

    Report

    Report Number
    3008261720-2018-02742
    Event Type
    Malfunction
    Date Received
    June 22, 2018
    Date of Event
    May 11, 2018
    Report Date
    June 22, 2018
    Manufacturer
    NEODENT JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568805
    PMA / PMN Number
    K101945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    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 REPORT ON BEHALF OF NEODENT - JJGC.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 10 DAYS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 22 IN THE MOUTH, THE IMPLANT HAD NOT ACHIEVED INTEGRATION. CLINICIAN REPORTS PATIENT EXPERIENCED NUMBNESS. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 10 DAYS S AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 22 IN THE MOUTH, THE IMPLANT HAD NOT ACHIEVED INTEGRATION. CLINICIAN REPORTS PATIENT EXPERIENCED NUMBNESS. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO FURTHER COMPLICATIONS REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472738 CM TITAMAX IMPL TI 4.0X9 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT JJGC S.A. 124024 07898237568805

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention ABUTMENT REMOVAL| ABUTMENT REMOVAL