BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBUNION SYSTEM

    MDR report key: 10505307 · Received September 8, 2020

    Report

    Report Number
    3011421599-2020-00014
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 10, 2020
    Report Date
    September 8, 2020
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HRS
    PMA / PMN Number
    K190658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED ON (B)(6) 2020 THAT THE OBLIQUE PROXIMAL SCREW WAS FRACTURED. FUSION HAS NOT OCCURRED, AND REVISION SURGERY IS SCHEDULED. IMPLANT DATE AND PATIENT INFORMATION WAS NOT PROVIDED. POST-OPERATIVE AND FOLLOW-UP X-RAYS WERE PROVIDED. REVISION SURGERY IS SCHEDULED FOR (B)(6) 2020; NO ADDITIONAL DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2020 THAT THE OBLIQUE PROXIMAL SCREW WAS FRACTURED. FUSION HAS NOT OCCURRED, AND REVISION SURGERY IS SCHEDULED. IMPLANT DATE AND PATIENT INFORMATION WAS NOT PROVIDED. POST-OPERATIVE AND FOLLOW-UP X-RAYS WERE PROVIDED. REVISION SURGERY IS SCHEDULED FOR (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965715 MINIBUNION SYSTEM PLATE, FIXATION, BONE HRS CROSSROADS EXTREMITY SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention