BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPRACONDYLAR NAIL T2 SCN Ø11X360MM

    MDR report key: 3735865 · Received April 9, 2014

    Report

    Report Number
    0009610622-2014-00160
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K023267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ACCORDING TO THE MEDICAL DETAILS THE SCN Ø11 X L360 MM WAS REVISED DUE TO NON-UNION WITH A SCN Ø 13 X L 340 MM 29 WEEKS AFTER IMPLANTATION. A MALFUNCTION OR FAILURE OF THE DEVICE WAS NOT REPORTED. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO DISCREPANCIES FOUND DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    PATIENT HAD A NON-UNION OF THEIR LEFT DISTAL FEMUR. SCN NAIL WAS PULLED AND SYNTHES RIA REAMER WAS USED AND A 13/340 SCN WAS PLACED BACK IN PATIENT.

    Description of Event or Problem · 1

    PATIENT HAD A NON-UNION OF THEIR LEFT DISTAL FEMUR. SCN NAIL WAS PULLED AND SYNTHES RIA REAMER WAS USED AND A 13/340 SCN WAS PLACED BACK IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213492 SUPRACONDYLAR NAIL T2 SCN Ø11X360MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K131717

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention