BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 3.5X10

    MDR report key: 7889458 · Received September 19, 2018

    Report

    Report Number
    3008261720-2018-04656
    Event Type
    Injury
    Date Received
    September 19, 2018
    Date of Event
    August 13, 2018
    Report Date
    December 4, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878023333
    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 REPORT ON BEHALF OF NEODENT - JJGC. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS SELECTED AN IMPLANT DESIGN WHICH IS NOT RECOMMENDED FOR THE PATIENT'S BONE QUALITY. THE DENTIST ALSO REPORTED THAT IMMEDIATE LOAD PROCEDURE WAS PERFORMED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS SELECTED AN IMPLANT DESIGN WHICH IS NOT RECOMMENDED FOR THE PATIENT'S BONE QUALITY. THE DENTIST ALSO REPORTED THAT IMMEDIATE LOAD PROCEDURE WAS PERFORMED.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 2 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE II BONE. CLINICIAN REPORTS PATIENT'S BONE DEFECT AND BLEEDING. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 2 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE II BONE. CLINICIAN REPORTS PATIENT'S BONE DEFECT AND BLEEDING. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS. (B)(4).

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 2 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE II BONE. CLINICIAN REPORTS PATIENT'S BONE DEFECT AND BLEEDING. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731751 CM DRIVE IMPLANT 3.5X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800311206I 07899878023333

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GRAFT| GRAFT| GRAFT| GRAFT