BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALAXO SCREW, 7MM X 20MM

    MDR report key: 1577414 · Received January 6, 2010

    Report

    Report Number
    1219602-2010-00002
    Event Type
    Malfunction
    Date Received
    January 6, 2010
    Report Date
    December 1, 2009
    Manufacturer
    MANSFIELD MFG SITE
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT DID NOT OCCUR WITHIN THE EUROPEAN ECONOMIC AREA AND DID NOT INVOLVE CORRECTIVE ACTION. THIS INCIDENT HAS BEEN DETERMINED NOT TO BE A MDV REPORTABLE INCIDENT. PRODUCT RECALL WAS INITIATED AUGUST 21, 2007. (B) (4)

    Description of Event or Problem · 1

    ON (B) (6) 2007 - PT RECEIVED SURGERY ON HER LEFT KNEE, ACL RECONSTRUCTION USING A CALAXO SCREW. SHE EXPERIENCED SWELLING AND DISCOMFORT. SEVENTEEN MONTHS AFTER SURGERY SHE STILL FELT PAIN. TWO YEARS LATER, SHE STILL COMPLAINS OF DISCOMFORT ALONG HER LEFT PROXIMAL TIBIA. HER DIAGNOSIS IS A LEFT TIBIAL CYST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALAXO SCREW, 7MM X 20MM CALAXO SCREW, 7MM X 20MM / HWC HWC MANSFIELD MFG SITE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR