BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT, TITANIUM 4.3 X 11.5 MM

    MDR report key: 7097439 · Received December 7, 2017

    Report

    Report Number
    3008261720-2017-06683
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    October 6, 2017
    Report Date
    December 7, 2017
    Manufacturer
    NEODENT JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878023302
    PMA / PMN Number
    K123022
    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 REPORTON BEHALF OF NEODENT - JJGC

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT ON THE DAY THE DENTAL IMPLANT WAS PLACED, FAILURE OCCURRED UPON INSERTION. CLINICAL REPORTED POOR PACKAGING/DESIGN-CONNECTION BETWEEN CARRIER AND IMPLANT HEAD. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. NO FURTHER COMPLICATIONS WERE OBSERVED.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT ON THE DAY THE DENTAL IMPLANT WAS PLACED, FAILURE OCCURRED UPON INSERTION. CLINICAL REPORTED POOR PACKAGING/DESIGN-CONNECTION BETWEEN CARRIER AND IMPLANT HEAD. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. NO FURTHER COMPLICATIONS WERE OBSERVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874622 CM DRIVE IMPLANT, TITANIUM 4.3 X 11.5 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT JJGC S.A. 800234882I 07899878023302

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention