BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL NAIL, STANDARD T2 TIBIA 14X360 MM

    MDR report key: 3902037 · Received June 30, 2014

    Report

    Report Number
    0009610622-2014-00289
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 4, 2014
    Report Date
    December 17, 2020
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K003018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR INVESTIGATION. IF FURTHER INFORMATION BECOME AWARE, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    PATIENT HAD STANDARD T2 TIBIA NAIL IN RIGHT TIBIA. PATIENT HAD PAIN IN DISTAL AND PROXIMAL AREAS OF TIBIA (WHERE PROXIMAL AND DISTAL SCREWS WERE PLACED). SURGEON PERFORMED EXTRACTION OF NAIL, END CAP, 5.0 PROXIMAL FULLY THREADED LOCKING SCREW, 5.0 FULLY THREADED DISTAL LOCKING SCREW, AND 5.0 FULLY THREADED DISTAL LOCKING SCREW. SURGERY WAS ROUTINE. NO REPLACEMENT DEVICE WAS USED. REP REPORTED THAT "NONE OF THE HARDWARE REMOVED WAS BROKEN. THE DEVICES EXTRACTED WERE PRIMARY PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381028 TIBIAL NAIL, STANDARD T2 TIBIA 14X360 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention