BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GM DRIVE ACQUA IMPLANT 3.5X8 MM

    MDR report key: 7828825 · Received August 29, 2018

    Report

    Report Number
    3008261720-2018-03223
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    May 28, 2018
    Report Date
    August 29, 2018
    Manufacturer
    NEODENT - JJGC S.A.
    Product Code
    DZE
    UDI-DI
    07899878025030
    PMA / PMN Number
    K163194
    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. K163194.

    Description of Event or Problem · 0

    (B)(4)¿THE DENTIST REPORTED THAT 27 DAYS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 29#, IT HAD TO BE REMOVED BECAUSE THE PATIENT WAS IN PAIN. THE PATIENT PRESENTED BONE TYPE III AND IMMEDIATE IMPLANT WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669435 GM DRIVE ACQUA IMPLANT 3.5X8 MM ENDOSSEOUS DENTAL IMPLANT DZE NEODENT - JJGC S.A. 800312211 07899878025030

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention