BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPIO-FLEX PS TIBIAL TRIAL

    MDR report key: 1944737 · Received December 9, 2010

    Report

    Report Number
    2249697-2010-01710
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    2249697-07/26/10-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME EVENT AS: MFR # 2249697-2010-01706; MFR # 2249697-2010-01707; MFR # 2249697-2010-01708; MFR # 2249697-2010-01709.

    Description of Event or Problem · 1

    IT WAS REPORTED, "THESE PRODUCTS DID NOT PASS THE INSPECTION FOR RA2009-356."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO-FLEX PS TIBIAL TRIAL INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA PPMXL13

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other