BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACETCORE SYSTEM

    MDR report key: 12778288 · Received November 9, 2021

    Report

    Report Number
    3012495575-2021-00002
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 19, 2021
    Report Date
    October 26, 2021
    Manufacturer
    SURGENTEC, LLC
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE PHYSICIAN WAS DOING AN OPEN CASE, WHILE TARGETING WITH THE FACET LOCATOR BY VISUALIZATION, THE IMPACTOR WAS PLACED OVER THE FACET LOCATOR AND MALLETED TO HELP DRIVE THE FACET LOCATOR INTO THE PROPER POSITION. THE DRILL GUIDE WAS THE PLACED OVER THE FACE LOCATOR. WHEN THE PHYSICIAN TRIED TO REMOVE THE FACE LOCATOR, IT WOULD NOT COME OUT, IT TOOK SOME TIME AND FORCE TO REMOVE THE FACET LOCATOR FROM ITS' POSITION AND WHEN REMOVED, ONE OF THE DISTAL TINES OF THE FACET LOCATOR WAS NO LONGER ATTACHED. UPON FURTHER INSPECTION AND IMAGING THE TINE WAS LODGED IN THE BONE OF THE FACET JOINT AND COULD NOT BE REMOVED. SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATION AND FACET LOCATOR ISSUE DID NOT ADD MUCH TIME TO OVERALL SURGERY.

    Description of Event or Problem · 0

    THE PHYSICIAN WAS DOING AN OPEN CASE, WHILE TARGETING WITH THE FACET LOCATOR BY VISUALIZATION, THE IMPACTOR WAS PLACED OVER THE FACET LOCATOR AND MALLETED TO HELP DRIVE THE FACET LOCATOR INTO THE PROPER POSITION. THE DRILL GUIDE WAS THE PLACED OVER THE FACE LOCATOR. WHEN THE PHYSICIAN TRIED TO REMOVE THE FACE LOCATOR, IT WOULD NOT COME OUT, IT TOOK SOME TIME AND FORCE TO REMOVE THE FACET LOCATOR FROM ITS' POSITION AND WHEN REMOVED, ONE OF THE DISTAL TINES OF THE FACET LOCATOR WAS NO LONGER ATTACHED. UPON FURTHER INSPECTION AND IMAGING THE TINE WAS LODGED IN THE BONE OF THE FACET JOINT AND COULD NOT BE REMOVED. SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATION AND FACET LOCATOR ISSUE DID NOT ADD MUCH TIME TO OVERALL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675120 FACETCORE SYSTEM FACETCORE LOCATOR MDM SURGENTEC, LLC NA SM114620

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown