BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE IMPLANT 3.5X10

    MDR report key: 7828917 · Received August 29, 2018

    Report

    Report Number
    3008261720-2018-03293
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    May 30, 2018
    Report Date
    November 1, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878023340
    PMA / PMN Number
    K123022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. AFTER THE EVALUATION WAS NOTICED THAT THE ITEM RECEIVED IS DIFFERENT FROM THE ITEM REPORTED. THEREFORE, THE LOT NUMBER WAS NOT CONSIDERED.

    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.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THAT 3 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 5 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE INTEGRATION IN TYPE II BONE. CLINICIAN REPORTS A LOCAL INFECTION. 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 REPORTS THAT 3 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 5 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE INTEGRATION IN TYPE II BONE. CLINICIAN REPORTS A LOCAL INFECTION. 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 REPORTS THAT 3 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 5 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE INTEGRATION IN TYPE II BONE. CLINICIAN REPORTS A LOCAL INFECTION. 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
    669760 CM DRIVE IMPLANT 3.5X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800311224I 07899878023340

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention ABUTMENT PLACEMENT| ABUTMENT PLACEMENT| ABUTMENT PLACEMENT