BEUDAMED
    FDA Adverse Event Other Summary report: N

    CALAXO SCREW

    MDR report key: 1001446 · Received February 14, 2008

    Report

    Report Number
    1219602-2008-00035
    Event Type
    Other
    Date Received
    February 14, 2008
    Report Date
    January 18, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PT REPORTS PAIN AND TENDERNESS AT THE BUMP 1/2 INCH IN DIAMETER IN AREA OF CALAXO IMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK