BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACETCORE SYSTEM

    MDR report key: 10935778 · Received December 2, 2020

    Report

    Report Number
    3012495575-2020-00001
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 10, 2020
    Report Date
    November 10, 2020
    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 · 1

    ONE OF TWO DISTAL PRONGS OF THE FACET LOCATOR APPEARED TO HAVE BEEN BROKEN OFF BECAUSE THE EXISTING ROD & SCREW CONSTRUCT HINDERED THE DEPLOYMENT OF THE INSTRUMENT. IN DOING SO, ONE OF THE PRONGS MAY HAVE GOTTEN CAUGHT UP ON THE SCREW, SET SCREW, AND ROD INTERFACE CAUSING IT TO BREAK OFF UPON IMPACTION. IT IS BELIEVED THE PRONG IS LODGED NEXT TO THE EXISTING CONSTRUCT AS IT COULD NOT BE FOUND WITH IMAGING. AS PER THE REPRESENTATIVE THE SURGEON WAS USING EXCESSIVE FORCE MALLETING THE FACET LOCATOR AGAINST AN EXISTING CONSTRUCT WITCH LED TO THE INSTRUMENT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402302 FACETCORE SYSTEM FACET LOCATOR MDM SURGENTEC, LLC NA SM114620

    Patients

    Seq Age Sex Outcome Treatment
    1