BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPIO-FLEX PS TIBIAL TRIAL

    MDR report key: 1962890 · Received December 22, 2010

    Report

    Report Number
    2249697-2010-01860
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 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

    DEVICE MANUFACTURE DATE FOR LOT # PPWT07: (B)(4) 2003. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THESE PRODUCTS DID NOT PASS THE INSPECTION FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO-FLEX PS TIBIAL TRIAL INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA PPMYT28

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other