BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 4.3X11.5

    MDR report key: 8537730 · Received April 22, 2019

    Report

    Report Number
    3008261720-2019-01657
    Event Type
    Injury
    Date Received
    April 22, 2019
    Date of Event
    December 3, 2018
    Report Date
    April 22, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016526
    PMA / PMN Number
    K133592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. (B)(4). THE INFORMATION PROVIDED IN THIS REPORT WAS BASED ON INFORMATION GIVEN BY THE DENTIST IN NEODENT¿S PRODUCTS WARRANTY FORM THAT WAS RECORDED IN THE SYSTEM THAT IS USED BY BOTH THE MANUFACTURER AND THE SUBSIDIARY. THE ORIGINAL COMPLAINT AND THE PRODUCT WERE RECEIVED BY THE SUBSIDIARY AND DID NOT ARRIVE IN THE MANUFACTURER YET. WHEN THIS HAPPENS, A NEW EVALUATION OF THE COMPLAINT WILL BE CARRIED OUT AND, IF NECESSARY, A NEW FOLLOW-UP REPORT WILL BE SEND.

    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 3.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 28 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. THE CLINICIAN NOTED THE INTERNAL THREADS OF THE PATIENT'S IMPLANT WERE STRIPPED. THE IMPLANT WAS INSTALLED RIGHT AFTER TOOTH EXTRACTION. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 3.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 28 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. THE CLINICIAN NOTED THE INTERNAL THREADS OF THE PATIENT'S IMPLANT WERE STRIPPED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329298 CM DRIVE IMPLANT 4.3X11.5 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 122724I 07899878016526

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention