BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBUNION SYSTEM

    MDR report key: 10557692 · Received September 19, 2020

    Report

    Report Number
    3011421599-2020-00015
    Event Type
    Malfunction
    Date Received
    September 19, 2020
    Date of Event
    August 21, 2020
    Report Date
    September 18, 2020
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HRS
    UDI-DI
    00815432027149
    PMA / PMN Number
    K190658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT REMOVAL SURGERY APPROXIMATELY 9 MONTHS AFTER IMPLANTATION DUE TO PROMINENCE DUE TO EXOSTOSIS. THE PATIENT WAS ASYMPTOMATIC PRIOR TO REMOVAL SURGERY. THE PATIENT HAS NO KNOWN ALLERGIES. DURING THE REMOVAL, THE SURGEON OBSERVED BLACK SOFT TISSUE (METALLOSIS) IN THE ENTIRE CANAL AND THE SURFACE OF THE MINIBUNION PLATE. THE IMPLANT WAS REMOVED WITHOUT COMPLICATION. REVIEW OF PRODUCT RECORDS CONFIRM ALL COMPONENTS CONFORM TO ASTM F136 TI-6AL-4V TITANIUM ALLOY. NO NONCONFORMANCE WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT REMOVAL SURGERY APPROXIMATELY 9 MONTHS AFTER IMPLANTATION DUE TO PROMINENCE DUE TO EXOSTOSIS. THE PATIENT WAS ASYMPTOMATIC PRIOR TO REMOVAL SURGERY. THE PATIENT HAS NO KNOWN ALLERGIES. DURING THE REMOVAL, THE SURGEON OBSERVED BLACK SOFT TISSUE (METALLOSIS) IN THE ENTIRE CANAL AND THE SURFACE OF THE MINIBUNION PLATE. THE IMPLANT WAS REMOVED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022093 MINIBUNION SYSTEM PLATE, FIXATION, BONE HRS CROSSROADS EXTREMITY SYSTEMS 3100-0030 500737 00815432027149

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention