BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM TITAMAX IMPL TI 3.5X11

    MDR report key: 7030136 · Received November 14, 2017

    Report

    Report Number
    3008261720-2017-05282
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    March 30, 2017
    Report Date
    January 17, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568683
    PMA / PMN Number
    K101207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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.

    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

    (B)(4) - THE CLINICIAN REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN ADA SITE#24 OF THE PATIENT'S MOUTH, NON-OSSEOINTEGRATION WAS OBSERVED. THE CLINICIAN REPORTS DID NOT INTEGRATE. THE PATIENT IS ALLERGIC TO TETRACYCLINE. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Description of Event or Problem · 0

    (B)(4) - THE CLINICIAN REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN ADA SITE#24 OF THE PATIENT'S MOUTH, NON-OSSEOINTEGRATION WAS OBSERVED. THE CLINICIAN REPORTS DID NOT INTEGRATE. THE PATIENT IS ALLERGIC TO TETRACYCLINE. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN ADA SITE#24 OF THE PATIENT'S MOUTH, NON-OSSEOINTEGRATION WAS OBSERVED. THE CLINICIAN REPORTS DID NOT INTEGRATE.THE PATIENT IS ALLERGIC TO TETRACYCLINE. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810283 CM TITAMAX IMPL TI 3.5X11 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800152943 07898237568683

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention