BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GPS BAR 4-6 IMPLANTS

    MDR report key: 6143439 · Received December 2, 2016

    Report

    Report Number
    3001617766-2016-00004
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 14, 2016
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING, LLC
    Product Code
    NHA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE STILL HAVE NOT BEEN RETURNED.

    Description of Event or Problem · 1

    THE DEVICE, AN OVER-DENTURE BAR BROKE IN THE PATIENT'S MOUTH. WHEN THE DEVICE BROKE, IT CUT THE PATIENT'S GINGIVA. THE DEVICE BROKE DURING MASTICATION. THE PATIENT CAME BACK TO THE DENTIST'S OFFICE AND WAS EXAMINED AND THE DENTIST PERFORMED A VISUAL INSPECTION. THE DENTIST THEN PROCEEDED TO REMOVE THE BROKEN DEVICE. THE PATIENT HAS FULLY RECOVERED AND IS AWAITING ON A NEW BAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793053 GPS BAR 4-6 IMPLANTS OVERDENTURE BAR NHA IMPLANT DIRECT SYBRON MANUFACTURING, LLC 1000-69-ODG 77488

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention