BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNACLIP

    MDR report key: 21251387 · Received January 28, 2025

    Report

    Report Number
    21251387
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    December 12, 2024
    Report Date
    January 16, 2025
    Manufacturer
    MEDSHAPE, INC.
    Product Code
    JDR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHEN OPENING AN IMPLANT FOR PATIENT, THE REGISTERED NURSE (RN) CHECKED THE EXPIRATION DATE ON THE OUTER BOX AND THE INNER PACKAGE AND IT SHOWED 12.31.24, BUT WHEN THE RN WENT TO SCAN THE IMPLANT INTO EPIC, AN EXPIRATION DATE OF 12.1.24 SHOWED UP. THE DECISION WAS MADE TO USE THE IMPLANT BECAUSE ALL OF THE PACKAGING SHOWED THE IMPLANT WAS NOT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2397026 DYNACLIP STAPLE, FIXATION, BONE JDR MEDSHAPE, INC. 5086

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Unknown