BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3" 19G STRAIGHT DEK KIT

    MDR report key: 4897958 · Received July 8, 2015

    Report

    Report Number
    0001811755-2015-02444
    Event Type
    Injury
    Date Received
    July 8, 2015
    Date of Event
    June 1, 2011
    Report Date
    June 10, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K032473
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DECOMPRESSOR KIT WAS USED ON A PATIENT IN SURGERY AND PART OF THE FLEXIBLE TIP WAS LEFT IN THE NECK OF THE PATIENT. THIS WAS DISCOVERED DURING AN MRI, WHEN THE PATIENT HAD PAIN. A REVISION SURGERY MAY BE COMPLETED. NO OTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DECOMPRESSOR KIT WAS USED ON A PATIENT IN SURGERY AND PART OF THE FLEXIBLE TIP WAS LEFT IN THE NECK OF THE PATIENT. THIS WAS DISCOVERED DURING AN MRI, WHEN THE PATIENT HAD PAIN. A REVISION SURGERY MAY BE COMPLETED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441897 3" 19G STRAIGHT DEK KIT ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention