BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM DRIVE IMPLANT 3.5X10

    MDR report key: 7447727 · Received April 20, 2018

    Report

    Report Number
    3008261720-2018-01827
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    December 23, 2017
    Report Date
    April 20, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878024309
    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 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

    RP 011243 - THE DENTIST REPORTED THAT 2 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 29#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 45NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290604 GM DRIVE IMPLANT 3.5X10 ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800302458 07899878024309

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention