BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-WIRE

    MDR report key: 16616005 · Received March 24, 2023

    Report

    Report Number
    3008650117-2023-00063
    Event Type
    Injury
    Date Received
    March 24, 2023
    Date of Event
    December 27, 2022
    Report Date
    March 24, 2023
    Manufacturer
    PARAGON 28, INC.
    Product Code
    HXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LIMITED INFORMATION IS KNOWN ABOUT THIS EVENT AND THE PART INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED TITANIUM ALLERGY FROM SURGICAL IMPLANTS. NO ALLEGATION OF DEVICE DEFICIENCY OR DEVICE MALFUNCTION IS ASSOCIATED WITH PATIENT REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486647 K-WIRE HXI PARAGON 28, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention