BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALKYRIE THORACIC FIXATION SYSTEM

    MDR report key: 16483153 · Received March 3, 2023

    Report

    Report Number
    3014680795-2023-00002
    Event Type
    Injury
    Date Received
    March 3, 2023
    Date of Event
    February 2, 2023
    Report Date
    March 2, 2023
    Manufacturer
    J.M. LONGYEAR MANUFACTURING, LLC
    Product Code
    HRS
    UDI-DI
    00810071390012
    PMA / PMN Number
    K202889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED AND IS NOT AVAILABLE FOR INVESTIGATION. A DHR REVIEW WAS CONDUCTED OR CONFIRMED THAT THE DEVICE(S) MET SPECIFICATION PRIOR TO SHIPPING. THIS REPORT WILL BE UPDATED SHOULD THIS INFORMATION BECOME AVAILABLE AT A LATER DATE.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY CORRECT D4 AND G4 CONTENT TO ALIGN WITH GUDID.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A DISTRIBUTOR THAT A VALKYRIE RE OPERATION PROCEDURE OCCURRED IN A PATIENT. THE PATIENT WAS SEEN 11 DAYS POST OPERATIVELY AFTER EXPERIENCING A FALL AND COUGHING FIT. A RE OPERATION WAS INITIATED ON THE PATIENT AND NOTED STERNAL DEHISCENCE WITH THE OBSERVATION OF THE STERNAL CONSTRUCT FAILURE (PULL THROUGH OF WIRES AND FRACTURE OF PLATES). AS A FOLLOW UP, INTERVIEW WITH (B)(6), PA (HCP PRESENT IN THE ORIGINAL AND REVISION CASE) WAS CONDUCTED ON (B)(6) 2023. IT WAS NOTED THAT THE PATIENT'S BONE QUALITY WAS EXTREMELY POOR. THE X-PLATES AND THE V-PLATE FRACTURED AT THE MID-LINE, SCREWS REMAINED ATTACHED TO THE PLATES AND THE BONE. BLUNT FORCE TRAUMA MAY HAVE CONTRIBUTED TO THE EVENT. DURING THE INITIAL CLOSURE OF THE STERNUM, IT WAS NOTED THAT THE STERNUM BONE QUALITY WAS VERY POOR. PATIENT RECEIVED AN ADDITIONAL PROCEDURE TO REMOVE THE DEVICE, A WOUND VAC. AND MUSCLE FLAP WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826227 VALKYRIE THORACIC FIXATION SYSTEM X-PLATE HRS J.M. LONGYEAR MANUFACTURING, LLC 01-020 105622 00810071390012

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention