BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAFORCE STEP STAPLE

    MDR report key: 10097286 · Received May 28, 2020

    Report

    Report Number
    3011421599-2020-00010
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Report Date
    May 28, 2020
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    JDR
    PMA / PMN Number
    K181866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION TO STEP STAPLE WAS REPORTED. NO ADDITIONAL DETAILS ARE AVAILABLE. IF ADDITIONAL INFORMATION IS AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    A REVISION TO STEP STAPLE WAS REPORTED. NO ADDITIONAL DETAILS ARE AVAILABLE. IF ADDITIONAL INFORMATION IS AVAILABLE, THIS REPORT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562037 DYNAFORCE STEP STAPLE PLATE, FIXATION, BONE JDR CROSSROADS EXTREMITY SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention