BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBUNION SYSTEM

    MDR report key: 10469764 · Received August 30, 2020

    Report

    Report Number
    3011421599-2020-00013
    Event Type
    Malfunction
    Date Received
    August 30, 2020
    Date of Event
    July 31, 2020
    Report Date
    August 30, 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

    IT WAS REPORTED THAT THE SURGEON REMOVED THE METATARSAL HEAD SCREW, REPOSITIONED THE METATARSAL HEAD DUE TO PLANTARFLEXION AND PLACED THE SAME SCREW. THE ORIGINAL IMPLANT WAS PLACED (B)(6) 2020. THE REVISION WAS PERFORMED ON (B)(6) 2020. THE SURGEON CONCLUDED THAT THE PLANTARFLEXION WAS DUE TO INTRAOPERATIVE CORRECTION DEFICIENCY DUE TO LATERAL X-RAY VIEW. THE SURGEON WILL MOVE THE FLURO MACHINE IN THE FUTURE AS OPPOSED TO MOVING THE FOOT TO GET A TRUE LATERAL VIEW PERI-OPERATIVELY TO ENSURE PROPER ALIGNMENT. ADDITIONAL IMPLANTS INVOLVED IN THE INCIDENT INCLUDE: REF: (B)(4), LN: 500721, QTY: 1, PRODUCT NAME: MINIBUNION NON-LOCKING SCREW 2.7MM X 18MM, REF: (B)(4), LN: 501075, QTY: 1, PRODUCT NAME: MINIBUNION LOCKING SCREW3.0MM X 20MM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REMOVED THE METATARSAL HEAD SCREW, REPOSITIONED THE METATARSAL HEAD DUE TO PLANTARFLEXION AND PLACED THE SAME SCREW. THE ORIGINAL IMPLANT WAS PLACED (B)(6) 2020. THE REVISION WAS PERFORMED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934204 MINIBUNION SYSTEM PLATE, FIXATION, BONE HRS CROSSROADS EXTREMITY SYSTEMS 3100-0030 501029 00815432027149

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention