BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM HELIX ACQUA IMPLANT 3.5X11.5

    MDR report key: 7456153 · Received April 24, 2018

    Report

    Report Number
    3008261720-2018-01915
    Event Type
    Injury
    Date Received
    April 24, 2018
    Date of Event
    March 8, 2018
    Report Date
    April 24, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878024903
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2015015. CONSIDERING THE SURGICAL METHODOLOGY, IT WAS SEEN THAT THE DENTIST HAS USED MORE DRILLS THAN RECOMMENDED TO PERFORM THE IMPLANT INSTALLATION. THE PREMARKET ID IS K163194. THIS NUMBER CORRESPOND TO A NEW DEVICE WHICH HAS NOT BEEN UPDATED ON THE SOFTWARE SYSTEM USED TO SEND THE REPORT TO FDA, BECAUSE OF THAT THE G5 FIELD IS EMPTY. IN ADDITION, WE ARE ALREADY WORKING ON THE UPDATE OF THIS CODE ON THE SOFTWARE SYSTEM OF THE COMPANY.

    Description of Event or Problem · 0

    (B)(4) - THE DENTIST REPORTED THAT AFTER 1 MONTH DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 24#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 60 NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE I AND IMMEDIATE LOAD WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299637 GM HELIX ACQUA IMPLANT 3.5X11.5 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800309123 07899878024903

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention