BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL NAIL, STANDARD 10X390 MM

    MDR report key: 1638884 · Received March 17, 2010

    Report

    Report Number
    9610622-2010-00118
    Event Type
    Malfunction
    Date Received
    March 17, 2010
    Date of Event
    February 13, 2010
    Report Date
    February 23, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K003018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. NO EVALUATION WILL BE PERFORMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. THE THREE END CAPS ARE AS FOLLOWS: 1822-0010S LOT K983326, 1822-0005S LOT K128241, 1822-0006S LOT K495937.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE END CAPS WOULD NOT SCREW INTO T2 TIBIAL NAIL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL NAIL, STANDARD 10X390 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K417444

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other