BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOCLIP SUPERELASTIC FUSION SYSTEM

    MDR report key: 8453804 · Received March 26, 2019

    Report

    Report Number
    3011421599-2018-00002
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    January 17, 2018
    Report Date
    February 14, 2018
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS LLC
    Product Code
    JDR
    UDI-DI
    00815432023288
    PMA / PMN Number
    K142727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS UNDERWAY TO DETERMINE POTENTIAL CONTRIBUTING FACTORS OF FAILURE.

    Description of Event or Problem · 1

    DATE OF INITIAL SURGERY IS (B)(6) 2017. THE DOCTOR IMPLANTED TWO 9MM DYNAFORCE IMPLANTS DORSALLY ACCROSS THE FIRST IPJ. AT 4 WEEK ROUTINE POST-OP VISIT THE DOCTOR DISCOVERED 1 FRACTURED IMPLANT AND NON-UNION OF FUSION SITE. DOCTOR PLANS TO CONTINUE TO MONITOR PATIENT AND UPDATE US IF A REVISION SURGERY IS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247329 MOTOCLIP SUPERELASTIC FUSION SYSTEM SINGLE/MULTIPLE COMPONENT BONE FIXATION APPLIANCE, BONE STAPLE JDR CROSSROADS EXTREMITY SYSTEMS LLC 500068 00815432023288

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR