BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOCLIP SUPERELASITIC FIXATION SYSTEM

    MDR report key: 6239640 · Received January 10, 2017

    Report

    Report Number
    3011421599-2017-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2017
    Date of Event
    December 22, 2016
    Report Date
    January 10, 2017
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS, LLC
    Product Code
    JDR
    UDI-DI
    00850310006106
    PMA / PMN Number
    K142727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RECREATION OF FAILURE WAS ATTEMPTED IN A SIMULATED USE. THE SURGERY WAS AN ELECTIVE PROCEDURE AT THE REQUEST OF THE PATIENT TO REMOVE THE HARDWARE; SUCCESSFUL FUSION WAS ACHIEVED. THE BROKEN STAPLE LEG WAS LEFT IN THE PATIENT. BASED ON INVESTIGATION, OUR CONCLUSION IS THAT THE STAPLE LEG BROKE UPON REMOVAL.

    Description of Event or Problem · 1

    PATIENT REQUESTED REMOVAL OF HARDWARE AFTER SUCCESSFUL FUSION. JOINT WAS PROPERLY FUSED AND PATIENT IS NON-SYMPTOMATIC. ELECTIVE SURGERY TO REMOVE HARDWARE. AT TIME OF REMOVAL ONE LEG OF THE STAPLE BROKE DURING THE REMOVAL PROCESS AND WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22271 MOTOCLIP SUPERELASITIC FIXATION SYSTEM SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE/ BONE STAPLE JDR CROSSROADS EXTREMITY SYSTEMS, LLC 1442-1814 101482 00850310006106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other