BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREADED BAR 160MM

    MDR report key: 569412 · Received February 1, 2005

    Report

    Report Number
    2183449-2004-00009
    Event Type
    Injury
    Date Received
    February 1, 2005
    Date of Event
    December 13, 2004
    Report Date
    December 28, 2004
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JEC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SHEFFIELD FRAME/FIXATOR WAS APPLIED FOR CHARCOT FOOT RECONSTRUCTION. AT A FOLLOW-UP VISIT SEVEN MONTHS POST-OP IT WAS NOTICED THROUGH THE X-RAYS THAT 3 SCREWS (99-60165) AND A CONNECTING ROD (81038A) WERE BROKEN. THE DOCTOR REPLACED THE CONNECTING ROD, TWO BROKEN SCREWS, AND THEN HE ADDED A WIRE TO SUPPORT THE THIRD SCREW THAT WAS LEFT IN THE PT. SINCE THE THIRD SCREW BROKE IN THE MIDDLE OF THE BONE (THREADED PART OF THE SCREW) AND HAD A GOOD AND STABLE PURCHASE, THE DOCTOR DECIDED NOT TO REMOVE IT. THE PT CONTINUED TREATMENT WITH THE SHEFFIELD FRAME/FIXATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THREADED BAR 160MM EXTERNAL FIXATION JEC ORTHOFIX SRL 81038A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention