BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALKYRIE THORACIC FIXATION SYSTEM

    MDR report key: 17863579 · Received October 3, 2023

    Report

    Report Number
    3014680795-2023-00005
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    August 29, 2023
    Report Date
    October 3, 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
    NE, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION OF THE DESIGN HISTORY RECORD OF THE AFFECTED LOT WAS COMPLETED ON (B)(6) 2023 AND THE DEVICE MET ALL SPECIFICATIONS. UPON REVIEW OF THE RETURNED DEVICE, THERE WERE NO VISIBLE SIGNS THAT WOULD INDICATE A PRODUCT DEFECT OR NONCONFORMITY.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY CORRECT D4, H4, H5 CONTENT TO MATCH GUDID.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE DUE TO EVIDENCE OF STERNAL INSTABILITY FOLLOWING A SEVERE COUGHING FIT. IT WAS OBSERVED THAT STERNAL WIRES HAD PULLED THROUGH THE BONE AND AN X-PLATE HAD FRACTURED AT A SINGLE LOCATION. IT WAS NOTED THAT THE SCREWS WERE STILL SECURELY LOCKED INTO THE PLATE AS WELL AS FULLY INTACT TO BONE SUBSTRATE. THE DEVICE WAS EXPLANTED, RETAINED BY THE HOSPITAL, AND SENT BACK TO THE MANUFACTURER FOR FURTHER INVESTIGATION. A NEW DEVICE WAS IMPLANTED TO RE-CLOSE THE CHEST-WALL AND THERE WAS NO FURTHER HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589568 VALKYRIE THORACIC FIXATION SYSTEM X-PLATE HRS J.M. LONGYEAR MANUFACTURING, LLC 01-020 105871 00810071390531

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention