BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 4.3X11.5

    MDR report key: 8361818 · Received February 22, 2019

    Report

    Report Number
    3008261720-2019-00779
    Event Type
    Injury
    Date Received
    February 22, 2019
    Date of Event
    January 24, 2019
    Report Date
    February 22, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878023302
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT CODES (F10): 2091. 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 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 CODES (F10): 1994, 2091, 2104. 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 22 DAYS AFTER THE DENTAL IMPLANT AND HEALING ABUTMENT WERE PLACED IN ADA SITE 30 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE II BONE. CLINICIAN REPORTS PATIENT'S TRAUMA, BIO- MECHANICAL OVERLOAD, PAIN, MOBILITY, BLEEDING, SWELLING, INFLAMMATION AND HYPERSENSITIVITY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OP COMPLICATIONS. (B)(4).

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 22 DAYS AFTER THE DENTAL IMPLANT AND HEALING ABUTMENT WERE PLACED IN ADA SITE 30 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE II BONE. CLINICIAN REPORTS PATIENT'S TRAUMA, BIO- MECHANICAL OVERLOAD, PAIN, MOBILITY, BLEEDING, SWELLING, INFLAMMATION AND HYPERSENSITIVITY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OP COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154333 CM DRIVE IMPLANT 4.3X11.5 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 86912I 07899878023302

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention HEALING ABUTMENT PLACEMENT| HEALING ABUTMENT PLACEMENT| HEALING ABUTMENT PLACEMENT