BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL ALIGNMENT HANDLE

    MDR report key: 1739750 · Received June 9, 2010

    Report

    Report Number
    2249697-2010-00627
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    May 19, 2010
    Report Date
    May 19, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: UNIVERSAL ALIGNMENT HANDLE, CAT# 6541-4-806, LOT CZC09E, DEVICE MANUFACTURE DATE: 07/21/2005. UNIVERSAL ALIGNMENT HANDLE, CAT# 6541-4-806, LOT C1K10, DEVICE MANUFACTURE DATE: 10/26/2006. UNIVERSAL ALIGNMENT HANDLE, CAT# 6541-4-806, LOT CZC09, DEVICE MANUFACTURE DATE: 7/21/2005. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SWIVEL BLOCK ASSEMBLY SLIGHTLY CROOKED AND SHOWS ALIGNMENT ROD TO BE SLIGHTLY SLANTED WHEN INSERTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL ALIGNMENT HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA CZS05B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other