BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALAXO SCREW

    MDR report key: 1002066 · Received February 20, 2008

    Report

    Report Number
    MW5005630
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    June 20, 2007
    Report Date
    February 20, 2008
    Manufacturer
    SMITH AND NEPHEW
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD AN ACL REPAIR ON THE RIGHT KNEE IN 2006. IN 2007, I DEVELOPED A MASS JUST BELOW THE RIGHT KNEE. I HAD INTERMITTENT PAIN IN 2007. DURING THAT YEAR, I SAW THE SAME ORTHOPEDIC SURGEON AND HAD ANOTHER MRI ON THE RIGHT LEG THAT SHOWED A MASS. I HAD SURGERY IN TWO MONTHS LATER REQUIRING REMOVAL OF THE MASS, EXCISION OF A NEUROMA THAT DEVELOPED AND THE CUTTING OF A NERVE THAT WAS EMBEDDED IN THE MASS OF THE CALAXO SCREW. THE SURGEON IMPLANTED BONE GRAFT MATERIAL TO FILL THE VOID WHERE THE CALAXO SCREW USED TO BE. THE MASS MIMICKED INFECTION, SO THE GELATINOUS MASS WAS SENT TO PATHOLOGY. I HAVE BEEN CONTACTED BY THE COMPANY THAT MAKES THE SCREW. DATES OF USE: 2006 - 2007. DIAGNOSIS: ACL SURGERY IN 2007. CALAXO SCREW REMOVAL DUE TO GELATINOUS MASS THAT IT CAUSED. EVENT ABATED AFTER USE STOPPED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALAXO SCREW CALAXO SCREW HWC SMITH AND NEPHEW

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| S CALAXO SCREW