BEUDAMED
    FDA Adverse Event Injury Summary report: N

    END CAP, STANDARD T2 TIBIA Ø8 MM

    MDR report key: 5011024 · Received August 18, 2015

    Report

    Report Number
    0009610622-2015-00395
    Event Type
    Injury
    Date Received
    August 18, 2015
    Date of Event
    July 11, 2015
    Report Date
    July 25, 2015
    Manufacturer
    STRYKER TRAUMA KIEL (MDR)
    Product Code
    HSB
    PMA / PMN Number
    K003018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF RETURNED MATERIAL REVEALED THE END CAP NOT BEING AFFECTED - CONCOMITANT ITEM.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IY WAS REPORTED THAT T2 GTN SYSTEM WAS IMPLANTED ON (B)(6) 2013. THESE IMPLANTS WERE REMOVED ON (B)(6) 2015. THEN THE PATIENT COMPLAINED THE PAIN AND FOREIGN MATERIAL WAS CONFIRMED ON THE X-RAY IMAGE. ON (B)(6) 2015, THE MATERIAL WAS REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT T2 GTN SYSTEM WAS IMPLANTED ON (B)(6) 2013. THESE IMPLANTS WERE REMOVED ON (B)(6) 2015. THEN THE PATIENT COMPLAINED THE PAIN AND FOREIGN MATERIAL WAS CONFIRMED ON THE X-RAY IMAGE. ON (B)(6) 2015, THE MATERIAL WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545822 END CAP, STANDARD T2 TIBIA Ø8 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL (MDR) K156792

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention