BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALKYRIE THORACIC FIXATION SYSTEM

    MDR report key: 22992533 · Received September 8, 2025

    Report

    Report Number
    3014680795-2025-00034
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    August 19, 2025
    Report Date
    September 4, 2025
    Manufacturer
    J.M. LONGYEAR MANUFACTURING, LLC
    Product Code
    HRS
    PMA / PMN Number
    K232515
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. THIS REPORT MAY BE BASED ON INFORMATION THAT HAS NOT BEEN ABLE TO BE COMPLETELY INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION THAT THE REPORT CONSTITUTES AND ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THE PRODUCTS HAVE NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE A DHR REVIEW COULD NOT BE CONDUCTED. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. IF ADDITIONAL INFORMATION RELEVANT TO THE INVESTIGATION OR OTHER CONTENT OF THIS REPORT IS IDENTIFIED, THIS REPORT WILL BE UPDATED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3014680795-2025-00033; 3014680795-2025-00035; 3014680795-2025-00036

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT THAT UNDERWENT A STERNAL CLOSURE USING A VARIETY OF PLATES AND SCREWS ALONG WITH FIBER TAPE ON (B)(6), 2025 EXPERIENCED A STERNAL DEHISCENCE THAT CORRELATED WITH EXTREME COUGHING FITS. THE PATIENT UNDERWENT REVISION SURGERY TO CORRECT THE STERNAL DEHISCENCE. DURING REOPERATION IT WAS IDENTIFIED THAT ONE X-PLATE DISSOCIATED FROM THE BONE AND THE SECOND X-PLATE COMPLETELY FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2066403 VALKYRIE THORACIC FIXATION SYSTEM X-PLATE HRS J.M. LONGYEAR MANUFACTURING, LLC 01-020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R