BEUDAMED
    FDA Adverse Event Other Summary report: N

    LOCKING SCREW, FULLY THREADED ?5X45 MM

    MDR report key: 1617143 · Received February 23, 2010

    Report

    Report Number
    9610622-2010-00085
    Event Type
    Other
    Date Received
    February 23, 2010
    Date of Event
    February 5, 2010
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K003018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SALES REP REFERRED THAT: DURING THE SURGERY THE SURGEON OPENED THE EXTERNAL PACKAGE. THEN HE OPENED THE INNER PACKAGE OF THE ITEM INVOLVED AND INSIDE THE PACKAGE THERE WAS ONLY THE INTERNAL BLISTER. THERE WEREN'T BOTH THE ITEM AND THE LABELS. THE SURGEON REFERRED THAT THE PACKAGE WAS PERFECTLY WRAPPED AND ALSO THE BOX WAS UNDAMAGED. THE SURGEON ENDED THE SURGERY USING ANOTHER ITEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW, FULLY THREADED ?5X45 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K174941

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other