BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALKYRIE THORACIC FIXATION SYSTEM

    MDR report key: 17480350 · Received August 8, 2023

    Report

    Report Number
    3014680795-2023-00004
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 12, 2023
    Report Date
    August 8, 2023
    Manufacturer
    J.M. LONGYEAR MANUFACTURING, LLC
    Product Code
    HRS
    UDI-DI
    00810071390531
    PMA / PMN Number
    K202889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY FOR THE VALKYRIE PRODUCT FAMILY SHOWS THAT THERE HAVE BEEN NO PRIOR COMPLAINTS REGARDING PLATE FRACTURING DURING SURGERY. FURTHERMORE, NO PATIENT INJURY WAS REPORTED, AND THE SURGEON WAS ABLE TO PLACE A NEW IMPLANT. AN INVESTIGATION OF THE DESIGN HISTORY RECORD OF THE AFFECTED LOT WAS COMPLETED ON 7/18/2023 AND THE DEVICE MET ALL SPECIFICATIONS. THE RETURNED DEVICE WAS RECENTLY RECEIVED. IF THE RESULTS OF A PHYSICAL EVALUATION CHANGE THE OUTPUTS OF THE INVESTIGATION, THEN A REVISION TO THIS NARRATIVE WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY CORRECT D4 CONTENT TO MATCH GUDID.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN X-PLATE FRACTURED AROUND A SINGLE SCREW HOLE DURING SCREW INSERTION. IT WAS NOTED THAT THE SCREWS WERE INSERTED MULTIPLE TIMES, THE CADDY GUIDE WAS NOT USED, AND SCREWS WERE INSERTED FREE-HANDED INTO THE CONSTRUCT. THE FRACTURED PLATE WAS REMOVED, AND ANOTHER PLATE WAS IMPLANTED. THERE WAS NO HARM TO THE PATIENT NOR WAS THERE A SIGNIFICANT DELAY TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457855 VALKYRIE THORACIC FIXATION SYSTEM PLATE HRS J.M. LONGYEAR MANUFACTURING, LLC 01-020 105873 00810071390531

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other