BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE SYSTEM

    MDR report key: 1181690 · Received September 30, 2008

    Report

    Report Number
    9616680-2008-00300
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    December 20, 2007
    Report Date
    September 2, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT WAS REVISED IN 2007. ACCOLADE STEM REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE SYSTEM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 18283801

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention