BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBUNION SYSTEM

    MDR report key: 10353362 · Received July 31, 2020

    Report

    Report Number
    3011421599-2020-00012
    Event Type
    Malfunction
    Date Received
    July 31, 2020
    Date of Event
    July 29, 2020
    Report Date
    July 31, 2020
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HRS
    UDI-DI
    00815432027149
    PMA / PMN Number
    K190658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON IMPLANTED A SHORT MINIBUNION PLATE ON 4/13/2020. TEN (10) WEEKS POST-OPERATIVE X-RAY SHOW THAT THE JOINT HAS NOT HEALED. THE BUNION CORRECTION INCLUDES A LARGE SHIFT IN A LARGER PATIENT. THE SURGEON STATES THAT THE JOINT TOO MUCH DORSIFLEXION WHICH MAY NOT HEAL. THE PATIENT HAS INCREASED PAIN AND SWELLING OVER THE PAST 4 WEEKS DUE TO INCREASED RANGE OF MOTION; PAIN AND SWELLING RESOLVED AT 10 WEEKS. THE ORIGINAL MINIBUNION IMPLANT WAS REMOVED (B)(6) 2020. THE SURGEON REPLACED THE ORIGINAL IMPLANT WITH A LONGER MINIBUNION IMPLANT AND PLACED A BIOCRITICAL SCREW. NO ISSUES OCCURRED REMOVING THE ORIGINAL MINIBUNION. ADDITIONAL IMPLANTS INVOLVED IN THE INCIDENT INCLUDE: (B)(6).

    Description of Event or Problem · 1

    TEN (10) WEEKS POST-OPERATIVE X-RAY SHOW THAT THE JOINT HAS NOT HEALED. THE BUNION CORRECTION INCLUDES A LARGE SHIFT IN A LARGER PATIENT. THE SURGEON STATES THAT THE JOINT TOO MUCH DORSIFLEXION WHICH MAY NOT HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818088 MINIBUNION SYSTEM PLATE, FIXATION, BONE HRS CROSSROADS EXTREMITY SYSTEMS 3100-0030 500739 00815432027149

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention