BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALAXO SCREW

    MDR report key: 1953132 · Received January 7, 2011

    Report

    Report Number
    1219602-2011-00005
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Report Date
    December 9, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED POST-OP CONDITION WITH CYST FORMATION. (B)(6) 2006, RIGHT KNEE ARTHROSCOPIC AND OPEN ACL RECONSTRUCTION. (B)(6) 2006, NEW TRAUMA, HYPEREXTENSION OF KNEE, MRI INDICATES THAT ACL REPAIR IS INTACT, BONE MARROW EDEMA IN THE MEDIAL FEMORAL CONDYLE, SOFT TISSUE AND EDEMA SWELLING. (B)(6) 2006, A LITTLE BIT OF PAIN AND A BUMP OVER THE TIBIAL INCISION SITE. (B)(6) 2007, MRI INDICATES THAT INTEROSSEOUS CYST WITHIN THE PROXIMAL TIBIA AT THE SITE OF THE TIBIAL SCREW. THE CYST IS UP TO 4.0CM IN LARGEST DIAMETER. (B)(6) 2008, MRI INDICATES THAT THE CYST WITHIN THE FEMORAL AND TIBIAL TUNNEL IS SLIGHTLY SMALLER SINCE (B)(6) 2007. (B)(6) 2010, MRI INDICATES THAT STABLE APPEARANCE OF THE RIGHT KNEE SINCE 2008, THE CYST WITHIN THE FEMORAL AND TIBIAL TUNNELS OF THE ACL GRAFT ARE UNCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALAXO SCREW CALAXO SCREW,11MM X 30MM,STERILE BX OF 1 HWC SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 7211125 50128781

    Patients

    Seq Age Sex Outcome Treatment
    1