BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALAXO SCREW

    MDR report key: 1953201 · Received January 7, 2011

    Report

    Report Number
    1219602-2011-00007
    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, INDEX CALAXO PROCEDURE, LEFT KNEE REVISION ARTHROSCOPIC AND OPEN ACL RECONSTRUCTION (B)(6) 2007, MRI INDICATES THAT ACL GRAFT IS INTACT, THERE IS FLUID IN THE FEMORAL AND TIBIAL TUNNELS (B)(6) 2010, MRI INDICATES THAT LARGE POPLITEAL CYST, THIS IS INCREASED IN SIZE SINCE THE PREVIOUS STUDY, ACL GRAFT IS SEVERELY ATTENUATED AND LIKELY NON-FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALAXO SCREW CALAXO SCREW,11MM X 35MM,STERILE BX OF 1 HWC SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 7211126 50159377

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR