BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CM ALVIM IMPLANT 3.5X13 MM

    MDR report key: 7829179 · Received August 29, 2018

    Report

    Report Number
    3008261720-2018-03501
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    January 1, 2018
    Report Date
    August 29, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07898237568737
    PMA / PMN Number
    K101945
    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 USED MORE DRILLS THAN RECOMMENDED TO PERFORM THE IMPLANT INSTALLATION.

    Description of Event or Problem · 0

    RP.013120 ¿ THE DENTIST REPORTED THAT AFTER 8 DAYS DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 30#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE DENTIST ALSO INFORMED THAT THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668176 CM ALVIM IMPLANT 3.5X13 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 26706 07898237568737

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention