BEUDAMED
    FDA Adverse Event Other Summary report: N

    10X30 CALAXO SCREW

    MDR report key: 1001470 · Received February 19, 2008

    Report

    Report Number
    1219602-2008-00022
    Event Type
    Other
    Date Received
    February 19, 2008
    Report Date
    December 17, 2007
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIVISON
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED INFLAMMATORY REACTION WHICH RESULTED IN REOPERATION. NO OTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10X30 CALAXO SCREW 10X30 CALAXO SCREW HWC SMITH & NEPHEW INC., ENDOSCOPY DIVISON 7211123 50198469

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other