BEUDAMED
    FDA Adverse Event Other Summary report: N

    CALAXO SCREW

    MDR report key: 1051303 · Received May 22, 2008

    Report

    Report Number
    1219602-2008-00137
    Event Type
    Other
    Date Received
    May 22, 2008
    Report Date
    April 25, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT RECALL INITIATED AUGUST 21, 2007.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED POST-OP CYST-LIKE SWELLING OVER THE TIBIA. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALAXO SCREW CALAXO HWC SMITH & NEPHEW INC., ENDOSCOPY DIV. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA