BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALKYRIE THORACIC FIXATION SYSTEM

    MDR report key: 19784537 · Received July 19, 2024

    Report

    Report Number
    3014680795-2024-00011
    Event Type
    Injury
    Date Received
    July 19, 2024
    Date of Event
    May 1, 2023
    Report Date
    July 15, 2024
    Manufacturer
    J.M. LONGYEAR MANUFACTURING, LLC
    Product Code
    HRS
    PMA / PMN Number
    K232515
    Adverse Event
    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 D4 AND 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. AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN EXPLANTED, PRODUCT IS UNAVAILABLE FOR EVALUATION. LOT NUMBER DETAILS ARE UNAVAILABLE. IMAGERY IS NOT AVAILABLE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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: 3014680795-2024-00009; 3014680795-2024-00010; 3014680795-2024-00012; 3014680795-2024-00013; 3014680795-2024-00014.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT STERNAL CLOSURE USING A VARIETY OF PLATES AND SCREWS FOLLOWING A CORONARY ARTERY BYPASS GRAFT SURGERY IN (B)(6) 2023 WAS OBSERVED WITH INSTABILITY IN THE LOWER PORTION OF THE STERNUM AT A SUBSEQUENT FOLLOW-UP APPOINTMENT MORE THAN A YEAR LATER. A STERNAL DEHISCENCE IS PRESENT WITH IMPLANTS DISLOCATED FROM THEIR INTENDED POSITION. NO FOLLOW-UP SURGERY IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1753817 VALKYRIE THORACIC FIXATION SYSTEM PLATE HRS J.M. LONGYEAR MANUFACTURING, LLC 01-020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other