BEUDAMED
    FDA Adverse Event Other Summary report: N

    PIGALILEO CAS/NAV TKR SYSTEM

    MDR report key: 824712 · Received February 28, 2007

    Report

    Report Number
    2086141-2007-00009
    Event Type
    Other
    Date Received
    February 28, 2007
    Date of Event
    November 17, 2006
    Report Date
    January 29, 2007
    Manufacturer
    PLUS ORTHOPEDICS AG
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PLUS ORTHOPEDICS USA HAS REC'D A REPORT FROM A SURGEON OF A PT INDICATED AS HAVING A POST-SURGERY STATUS OF "EXCESSIVE VALGUS" OF THE LEFT LEG. BASED ON CONVERSATION BETWEEN PLUS USA AND THE SURGEON IT WOULD APPEAR THAT THE REASON FOR THE EXCESSIVE VALGUS CONDITION IS RELATED TO THE USE OF STANDARD INSTRUMENTATION IN CONJUNCTION WITH THE PLUS ORTHOPEDICS' PIGALILEO SYSTEM; WHICH REQUIRES PIGALILEO-SPECIFIC INSTRUMENTATION, NOT AVAILABLE TO THE SURGEON AT THAT TIME. THE PIGALILEO SYSTEM WAS NOT DESIGNED TO BE USED WITH EITHER STANDARD INSTRUMENTS OR MIS INSTRUMENTS. AS A RESULT AN ALIGNMENT ERROR APPARENTLY OCCURRED, RESULTING IN THE VALGUS CONDITION. ADDITIONAL DISCUSSIONS WITH THE SURGEON WILL OCCUR TO TRY AND ESTABLISH THE EXACT CAUSE OF THE VALGUS CONDITION OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIGALILEO CAS/NAV TKR SYSTEM HAW HAW PLUS ORTHOPEDICS AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other