BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOFIX LRS RAIL

    MDR report key: 303362 · Received November 3, 2000

    Report

    Report Number
    2183449-2000-00009
    Event Type
    Injury
    Date Received
    November 3, 2000
    Date of Event
    October 25, 2000
    Report Date
    October 31, 2000
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JEC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS BEING TREATED FOR A NON-UNION OF THE PROXIMAL RIGHT FEMUR. THE DR PERFORMED AN AUTOGRAFT AND APPLIED EXTERNAL FIXATION FOR COMPRESSION. THE DR USED A 25CM RAIL WITH AN LRS T CLAMP ON THE PROXIMAL END AND AN LRS SWIVEL CLAMP ON THE DISTAL END. RANCHO CUBES WERE USED AT BOTH ENDS TO ALLOW FOR ADDITIONAL PIN PLACEMENT IN THE LATERAL AND ANTERIOR PELVIS AND LATERAL AND ANTERIOR TIBIA. DURING TREATMENT, THE RAIL BROKE PROXIMALLY AT THE INSERTION OF THE T CLAMP WHICH HELD THE SCREWS IN THE LATERAL PELVIS. THE DISTAL SWIVEL CLAMP HELD THE SCREWS IN THE LATERAL DISTAL FEMUR. THE DR REPLACED THE RAIL AND PERFORMED ADDITIONAL GRATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOFIX LRS RAIL EXTERNAL FIXATION JEC ORTHOFIX SRL 55080 005I

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention