BEUDAMED
    FDA Adverse Event Other Summary report: N

    5CC HYDROSET INJECTABLE CEMENT

    MDR report key: 2163624 · Received June 10, 2011

    Report

    Report Number
    8010177-2011-00165
    Event Type
    Other
    Date Received
    June 10, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 20, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    GXP
    PMA / PMN Number
    K060763
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    BEFORE SURGERY (CRANIOPLASTY), THE SURGEON OPENED THE DEVICE AND THE LID WAS GLUED TO THE PACKAGING AND WAS NO LONGER STERILE. THE SURGEON ALSO FOUND A HAIR INSIDE THE PACKAGING OF THE DEVICE. THE SURGEON THEN USED ANOTHER PRODUCT AND THERE WAS NO DELAY AND NO ADVERSE CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5CC HYDROSET INJECTABLE CEMENT IMPLANT GXP STRYKER ORTHOPAEDICS LIMERICK NA M15S8IC00969

    Patients

    Seq Age Sex Outcome Treatment
    1 NA