BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACETCORE SYSTEM

    MDR report key: 17055425 · Received June 2, 2023

    Report

    Report Number
    3012495575-2023-00001
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    April 19, 2023
    Report Date
    May 2, 2023
    Manufacturer
    SURGENTEC, LLC
    Product Code
    MDM
    UDI-DI
    00058406007501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DURING A FACET SURGICAL TECHNIQUE, WITH ONE OF THE FACET LOCATOR INSTRUMENTS BEING USED (WHICH WAS INCLUDED IN THE IN THE INSTRUMENT TRAY), A DISTAL PRONG SNAPPED OFF UPON IMPACTING INTO THE JOINT AND A SMALL PIECE OF METAL (DISTAL PRONG) WAS LEFT IN PATIENT. NO EXTRA COMPLICATIONS AROSE FROM THIS, NO EXTRA TIME UNDER ANESTHESIA, NO CASE COMPLICATIONS, NO PATIENT PAIN WAS DOCUMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30405 FACETCORE SYSTEM FACETCORE LOCATOR MDM SURGENTEC, LLC NA SM122482 00058406007501

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown