BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DARCO PLATE

    MDR report key: 21468377 · Received February 26, 2025

    Report

    Report Number
    3010667733-2025-00201
    Event Type
    Injury
    Date Received
    February 26, 2025
    Date of Event
    January 27, 2025
    Report Date
    February 26, 2025
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING THE POST-MARKET SURVEILLANCE LITERATURE REVIEW. THE ARTICLE CAN BE FOUND AT HTTPS://WWW.INJURYJOURNAL.COM/ARTICLE/S0020-1383(21)00435-6/ABSTRACT. THE ALLEGED EVENT COULD NOT BE CONFIRMED, SINCE NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR OR THE ARTICLE. MORE DETAILED INFORMATION ABOUT THE PATIENT MEDICAL HISTORY, THE EVENT CIRCUMSTANCES, AND MEDICAL REPORTS MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A LITERATURE ENTITLED ¿RADIOGRAPHIC AND CLINICAL RESULTS OF MODIFIED 2-INCISION SINUS TARSI APPROACH FOR TREATMENT OF CALCANEUS FRACTURE¿, PUBLISHED IN 2021, WHICH IS ASSOCIATED WITH THE DARCO PLATES WHICH CAN BE REACHED AT HTTPS://WWW.INJURYJOURNAL.COM/ARTICLE/S0020-1383(21)00435-6/ABSTRACT. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND AT THIS TIME NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. ALLEGEDLY, THE AUTHOR INDICATED THAT 3/34 CASES (33 PATIENTS) EXPERIENCED WOUND COMPLICATION. THIS IS PATIENT # 3 OUT OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595083 UNKNOWN DARCO PLATE PLATE, FIXATION, BONE HRS WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other