BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACETCORESYSTEM

    MDR report key: 12778285 · Received November 9, 2021

    Report

    Report Number
    3012495575-2021-00003
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 22, 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

    GUIDEWIRE WAS PLACED INTO FACET JOINT, AND FACET LOCATOR WAS PLACED OVER THE GUIDEWIRE AND ADVANCED ALL THE WAY DOWN TO THE JOINT. 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 FACET LOCATOR. WHEN THE PHYSICIAN TRIED TO REMOVE THE FACET 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. SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATION AND FACET LOCATOR ISSUE DID NOT ADD MUCH TIME TO OVERALL SURGERY. IMAGING AFTER INSERTION OF DOWEL AND REMOVAL OF INSTRUMENTATION SHOWS THE DOWEL PLACED NORMALLY WITH THE TINE REMAINING IN THE BONE SUPERIOR TO WHERE THE DOWEL WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674817 FACETCORESYSTEM FACETCORE LOCATOR MDM SURGENTEC, LLC NA SM122482

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown