BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSTIE INTRAOSSEOUS FIXATION SYSTEM

    MDR report key: 5074904 · Received September 11, 2015

    Report

    Report Number
    3011421599-2015-00001
    Event Type
    Injury
    Date Received
    September 11, 2015
    Date of Event
    August 14, 2015
    Report Date
    August 27, 2015
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HWC
    PMA / PMN Number
    K141857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AT 2 MONTH FOLLOW-UP, PT COMPLAINED OF AN IRRITATION AND POSSIBLE CALLUS ON THE TOP OF TOE. IT APPEARED THE DORSAL ASPECT OF THE MIDDLE PHALANX BONE HAD BROKEN AND IMPLANT WAS PROTRUDING THROUGH THE TOP OF THE DORSAL ASPECT OF THE MIDDLE PHALANX. PT. WAS REPORTED TO HAVE COMPROMISED BONE QUALITY. IT WAS REPORTED THAT THE MIDDLE PHALANX COLLAPSED INTRA-OPERATIVELY. DURING THE OFFICE VISIT THE PT'S TOE WAS NUMBED, A SMALL INCISION OVER THE IRRITATION MADE AND THE PORTION OF THE IMPLANT THAT WAS PROTRUDING THROUGH THE BROKEN DORSAL ASPECT ODF THE BONE WAS TRIMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601111 CROSSTIE INTRAOSSEOUS FIXATION SYSTEM HWC CROSSROADS EXTREMITY SYSTEMS 1443-3310 100567

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention