BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM ALVIM ACQUA IMPLANT 3.5X10 MM

    MDR report key: 8579661 · Received May 3, 2019

    Report

    Report Number
    3008261720-2019-01873
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    March 22, 2019
    Report Date
    May 3, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016700
    PMA / PMN Number
    K150199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    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. MOREOVER, IT WAS SEEN THAT THE DENTIST HAS USED MORE DRILLS THAN RECOMMENDED TO PERFORM THE IMPLANT INSTALLATION. 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

    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. MOREOVER, IT WAS SEEN THAT THE DENTIST HAS USED MORE DRILLS THAN RECOMMENDED TO PERFORM THE IMPLANT INSTALLATION. 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

    (B)(4). THE DENTIST REPORTED THAT 6 MONTHS AND 4 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 10#, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE II).

    Description of Event or Problem · 0

    (B)(4) ¿ THE DENTIST REPORTED THAT 6 MONTHS AND 4 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 10#, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE II).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372879 CM ALVIM ACQUA IMPLANT 3.5X10 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800339472 07899878016700

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention