BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CM DRIVE IMPLANT, TITANIUM, 5.0X10 MM

    MDR report key: 7631552 · Received June 22, 2018

    Report

    Report Number
    3008261720-2018-02745
    Event Type
    Malfunction
    Date Received
    June 22, 2018
    Date of Event
    May 15, 2018
    Report Date
    June 22, 2018
    Manufacturer
    NEODENT JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878023364
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 4 IN THE MOUTH IN TYPE IV BONE, THE IMPLANT HAD NOT ACHIEVED OSSEOINTEGRATION. 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 5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 4 IN THE MOUTH IN TYPE IV BONE, THE IMPLANT HAD NOT ACHIEVED OSSEOINTEGRATION. 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
    472936 CM DRIVE IMPLANT, TITANIUM, 5.0X10 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT JJGC S.A. 800304567I 07899878023364

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention