BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANCELLOUS SCREW

    MDR report key: 11452 · Received January 14, 1994

    Report

    Report Number
    2916714-1993-00090
    Event Type
    Injury
    Date Received
    January 14, 1994
    Date of Event
    November 16, 1993
    Report Date
    December 17, 1993
    Manufacturer
    AESCULAP AG
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM A HOSPITAL ADMINISTRATOR STATED ATHAT TWO CANCELLOUS SCREWS, ONE OF WHICH WAS BROKEN, WERE REMOVED FROM A 39 YEAR OLD MALE PATIENT'S RIGHT FOOT. THE PATIENT HAD INITIALLY UNDERGONE ARTHRODESIS OF THE RIGHT METATARSAL WITH SCREW FIXATION AND BONE GRAFTING ON MARCH 10.1992 FOR AN INJURY SUSTAINED IN SEPTEMBER 1991. ON NOVEMBER 16, 1993 HE WAS RETURNED TO SURGERY FOR REMOVAL OF THE SCREWS. ONE SCREW WAS BROKEN AND THE DISTAL END REMAINS IMPLANTED IN THE PATIENT'S FOOT. THE PATIENT IS "DOING FINE" WITHOUT COMPLICATIONS. THE SCREWS WERE NOT RETURNED TO THE DISTRIBUTOR FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANCELLOUS SCREW Implant CANCELLOUS SCREW HWC AESCULAP AG

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R