BEUDAMED
    FDA Adverse Event Other Summary report: N

    CALAXO SCREW

    MDR report key: 1023727 · Received March 27, 2008

    Report

    Report Number
    1219602-2008-00072
    Event Type
    Other
    Date Received
    March 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT RECALL INITIATED ON 08/21/2007.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH POST-OP COMPLICATIONS AFTER ACL RECONSTRUCTION IN 2007. THE PT STATED THAT 6 WEEKS AFTER SURGERY, SHE STARTED PHYSICAL THERAPY AND HER KNEE STILL FELT LOOSE AND WOBBLY. ABOUT 2 MONTHS AGO, SHE DEVELOPED A CYST WHICH WAS VERY PAINFUL AND TENDER TO TOUCH. THE PT INDICATED THAT SHE THINKS ADDITIONAL SURGERY IS SCHEDULED, BUT IT HAS NOT BEEN CONFIRMED.

    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