BEUDAMED
    FDA Adverse Event Other Summary report: N

    CALAXO UNKNOWN SCREW SIZE

    MDR report key: 1160508 · Received September 12, 2008

    Report

    Report Number
    1219602-2008-00217
    Event Type
    Other
    Date Received
    September 12, 2008
    Report Date
    August 19, 2008
    Manufacturer
    SMITH & NEPHEW INC, ENDOSCOPY DIV
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT RECALL INITIATED 2007.

    Description of Event or Problem · 1

    PT INDICATED THAT SHE HAS HAD POST-OP PROBLEMS AS A RESULT OF CALAXO. NO OTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1