BEUDAMED
    FDA Adverse Event Other Summary report: N

    LONG NAIL KIT R1.5, TI, RIGHT 10X260MM X 125

    MDR report key: 1631245 · Received March 9, 2010

    Report

    Report Number
    9610622-2010-00101
    Event Type
    Other
    Date Received
    March 9, 2010
    Date of Event
    February 12, 2010
    Report Date
    February 16, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES REMAINS IMPLANTED. NO EVAL WILL BE PERFORMED. IF THE DEVICE OR ADD'L INFO BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, IN SURGERY USING THE G3 LONG NAIL THE SURGEON DIDN'T CONFIRM LEFT/RIGHT ON THE PACKAGE OF IMPLANT. ACTUALLY THE PT BROKEN HIS LEFT FEMUR, HOWEVER, THE SURGEON USED RIGHT NAIL FOR TREATMENT. AT THE END OF THE SURGERY, THE SURGEON FOUND THAT THE WRONG NAIL WAS USED, HOWEVER, HE DID NOT CHANGE THE LEFT NAIL. THE SURGEON CONFIRMED THAT THE NAIL WAS IMPLANTED GOOD POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R1.5, TI, RIGHT 10X260MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K267290

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention