BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM DRIVE ACQUA IMPLANT 4.3X10

    MDR report key: 8294504 · Received January 31, 2019

    Report

    Report Number
    3008261720-2019-00476
    Event Type
    Injury
    Date Received
    January 31, 2019
    Date of Event
    November 6, 2018
    Report Date
    January 31, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016892
    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. 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 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.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THAT 3 MONTHS AFTER THE IMMEDIATE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 7 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE II BONE. NO INFECTION WAS PRESENT. 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 MONTHS AFTER THE IMMEDIATE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 7 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE II BONE. NO INFECTION WAS PRESENT. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS. RP.017752.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84688 CM DRIVE ACQUA IMPLANT 4.3X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 133360 07899878016892

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention ABUTMENT REMOVAL| ABUTMENT REMOVAL| ABUTMENT REMOVAL