BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM ALVIM ACQUA IMPLANT 3.5X8 MM

    MDR report key: 8308327 · Received February 5, 2019

    Report

    Report Number
    3008261720-2019-00578
    Event Type
    Injury
    Date Received
    February 5, 2019
    Date of Event
    May 6, 2018
    Report Date
    February 5, 2019
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878016694
    PMA / PMN Number
    K150199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. THE DENTIST INSTALLED THE DENTAL IMPLANT AFTER ITS EXPIRATION DATE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. INSTRADENT USA, INC IS SUBMITTING THE REPORT ON BEHALF OF NEODENT - JJGC. THE DENTIST INSTALLED THE DENTAL IMPLANT AFTER ITS EXPIRATION DATE.

    Description of Event or Problem · 0

    (B)(6)¿ THE DENTIST REPORTED THAT 2 MONTHS AND 2 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 26#, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 15N.CM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE IV).

    Description of Event or Problem · 0

    RP.016701 ¿ THE DENTIST REPORTED THAT 2 MONTHS AND 2 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 26#, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 15N.CM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE IV).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99118 CM ALVIM ACQUA IMPLANT 3.5X8 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800171281 07899878016694

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention