BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 4.3X18

    MDR report key: 8372104 · Received February 26, 2019

    Report

    Report Number
    3008261720-2019-00784
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    December 14, 2018
    Report Date
    February 26, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878023470
    PMA / PMN Number
    K150182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT CODE (DESCRIPTION): ABSCESS. EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT. JJGC THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM, VISUAL CONFERENCE OF THE PRODUCT RETURNED BY THE DENTIST AND THE EVALUATION OF RELEVANT PRODUCTION RECORDS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT CODE (DESCRIPTION) (F10): ABSCESS. 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 OVER 4 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN THE MOUTH, THE IMPLANT DID NOT OSSEOINTEGRATE IN TYPE III BONE. CLINICIAN REPORTS THE PATIENT'S INFECTION, ABSCESS, INSUFFICIENT BONE QUALITY/QUALITY AND GOOD HYGIENE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST- OPERATIVE COMPLICATIONS. RP.017755.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT OVER 4 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN THE MOUTH, THE IMPLANT DID NOT OSSEOINTEGRATE IN TYPE III BONE. CLINICIAN REPORTS THE PATIENT'S INFECTION, ABSCESS, INSUFFICIENT BONE QUALITY/QUALITY AND GOOD HYGIENE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST- OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165399 CM DRIVE IMPLANT 4.3X18 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 94873I 07899878023470

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention