BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5 CANCELLOUS BONE SCREWS (80 MM X 2)

    MDR report key: 17682 · Received July 29, 1994

    Report

    Report Number
    17682
    Event Type
    Injury
    Date Received
    July 29, 1994
    Date of Event
    March 23, 1994
    Report Date
    March 28, 1994
    Manufacturer
    AESCULAP
    Product Code
    HWD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD ANKLE FUSION WITH SCREWS IMPLANTED ON 4/8/91. ON OCTOBER 18, 1991, REMOVAL OF 4 SCREWS AND ORIF WITH PLATE AND EIGHT SCREWS IMPLANTED FOR PSEUDOARTHROSISIN FEBRUARY ONSET OF PAIN IN RIGHT ANKLE WITH WEIGHT BEARING. ON 3/28/94, PATIENT RETURNED TO SURGERY FOR REMOVAL OF TUBULAR PLATE AND EIGHT SCREWS. FIVE PROXIMAL SCREWS WERE REMOVED FROM THE PLATE. THREE TRANSVERSE SCREWS (6.5 CANCELLOUS BONE SCREWS) WERE BROKEN AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5 CANCELLOUS BONE SCREWS (80 MM X 2) Implant BONE SCREWS HWD AESCULAP

    Patients

    Seq Age Sex Outcome Treatment
    1 84 * Hospitalization