BEUDAMED
    FDA Adverse Event Other Summary report: N

    LOCKING SCREW , FULLY THREADED 5X40 MM

    MDR report key: 1571783 · Received January 4, 2010

    Report

    Report Number
    9610622-2009-00444
    Event Type
    Other
    Date Received
    January 4, 2010
    Date of Event
    December 1, 2009
    Report Date
    December 1, 2009
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K003018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED, THE SURGEON ASK FOR A 40 MM LOCKING SCREW AND WHEN THE PACKAGE WAS OPENED THE WRONG LOCKING SCREW (50MM) WAS INSIDE THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW , FULLY THREADED 5X40 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other