BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALKYRIE THORACIC FIXATION SYSTEM

    MDR report key: 20326489 · Received September 27, 2024

    Report

    Report Number
    3014680795-2024-00019
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    August 27, 2024
    Report Date
    September 27, 2024
    Manufacturer
    J.M. LONGYEAR MANUFACTURING, LLC
    Product Code
    HWC
    UDI-DI
    00810071390692
    PMA / PMN Number
    K232515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY CORRECT H4 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 RETURNED TO THE MANUFACTURER FOR EVALUATION. 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: 3014680795-2024-00015; 3014680795-2024-00016; 3014680795-2024-00017; 3014680795-2024-00018.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT STERNAL CLOSURE USING A VARIETY OF PLATES AND SCREWS ALONG WITH STAINLESS-STEEL SUTURE IN (B)(6) 2024 EXPERIENCED A STERNAL DEHISCENCE AFTER AN EXTREME COUGHING FIT. IT WAS ALSO REPORTED THAT THE PLATES AND SCREW CONSTRUCT REMAINED INTACT, BUT PULLED AWAY FROM BONE, AND THE STAINLESS-STEEL SUTURE PULLED THROUGH THE STERNAL TISSUE. THE PATIENT UNDERWENT REVISION SURGERY TO CORRECT THE DEHISCENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738914 VALKYRIE THORACIC FIXATION SYSTEM SCREW HWC J.M. LONGYEAR MANUFACTURING, LLC 01-3013-2-HA 108626 00810071390692

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Hospitalization| R