BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALAXO DRIVERS & ACC

    MDR report key: 1960056 · Received January 13, 2011

    Report

    Report Number
    1219602-2011-00011
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    February 6, 2007
    Report Date
    December 15, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED.(B)(4)

    Description of Event or Problem · 1

    CALAXO CLAIM FORM RECEIVED FROM LEGAL. IFUM UPDATE CONFIRMED A POST OP CONDITION WITH TWO CALAXO SCREWS. (B)(6) 2006 INITIAL RT. KNEE ACL RECONSTRUCTION; (B)(6) 2007 PAIN AT TIBIAL TUNNEL; BUMP THAT IS UNCOMFORTABLE; (B)(6) 2007 POST RT KNEE EXOSTECTOMY; REMOVAL PORTION OF INTERFERENCE SCREW; CHRONIC INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALAXO DRIVERS & ACC CALAXO SCREW,9MM X 25MM,STERILE BOX OF 1 HWC SMITH & NEPHEW ENDOSCOPY 7211119 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention