BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALKYRIE THORACIC FIXATION SYSTEM

    MDR report key: 19742050 · Received July 15, 2024

    Report

    Report Number
    3014680795-2024-00008
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 1, 2024
    Report Date
    July 15, 2024
    Manufacturer
    J.M. LONGYEAR MANUFACTURING, LLC
    Product Code
    HWC
    PMA / PMN Number
    K232515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY CORRECT H5 CONTENT TO MATCH GUDID.

    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. IF ADDITIONAL INFORMATION RELEVANT TO THE INVESTIGATION OR OTHER CONTENT OF THIS REPORT IS IDENTIFIED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCREW MIGRATED FROM ITS INTENDED LOCATION. THE OCCURRENCE WAS DOCUMENTED ON AN X-RAY IMAGE TAKEN APPROXIMATELY 2-3 WEEKS POSTOPERATIVELY. THE PATIENT IS NOT EXPERIENCING ANY CLINICAL EFFECTS, NO FOLLOW-UP ACTIONS ARE PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459240 VALKYRIE THORACIC FIXATION SYSTEM SCREW HWC J.M. LONGYEAR MANUFACTURING, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male