BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CM ALVIN IMPLANT, TI 3.5 X 16

    MDR report key: 7629459 · Received June 22, 2018

    Report

    Report Number
    3008261720-2018-02741
    Event Type
    Malfunction
    Date Received
    June 22, 2018
    Date of Event
    May 7, 2018
    Report Date
    June 22, 2018
    Manufacturer
    NEODENT JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237569079
    PMA / PMN Number
    K101945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 18 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE #8 IN THE MOUTH, THE IMPLANT HAD NOT ACHIEVED OSSEOINTEGRATION, IMPLANT FRACTURED.. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 18 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE #8 IN THE MOUTH, THE IMPLANT HAD NOT ACHIEVED OSSEOINTEGRATION, IMPLANT FRACTURED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472806 CM ALVIN IMPLANT, TI 3.5 X 16 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT JJGC S.A. 31160 07898237569079

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention ABUTMENT REMOVAL| ABUTMENT REMOVAL| ABUTMENT REMOVAL