BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5 MM X 80 MM CANCELLOUS BONE SCREWS

    MDR report key: 14153 · Received April 20, 1994

    Report

    Report Number
    2916714-1994-00009
    Event Type
    Malfunction
    Date Received
    April 20, 1994
    Date of Event
    March 23, 1994
    Report Date
    April 7, 1994
    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

    PT HAD ANKLE FUSION WITH SCREWS WHICH WERE IMPLANTED ON 4/8/91. ON OCTOBER 18, 1991 THE ORIGINALL SCREWS (4) WERE REMOVED AND REPLACED WITH AN ORIF WITH PLATE AND EIGHT SCRREWS FOR PSEUDOARTHROSIS.IN FEBRUARY, 1994, PT COMPLAINED OF PAIN IN HER RIGHT ANKLE WHEN SHE PUT WEIGHT ON IT. RADIOGRAPHIC FINDINGS REVEALED THREE BROKEN SCREWS. ON 3/23/94, THE PT RETURNED TO SURGERY FOR REMOVAL OF THE PLATE EIGHT SCREWS. FIVE PROXIMAL SCREWS WERE REMOVED FROM THE PLATE. THREE TRANSVERSE SCREWS (6.5MM CANCELLOUS SCREWS) WERE FOUND BROKEN AND WERE REMOVED. THERE IS NO FURTHER INFORMATION OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5 MM X 80 MM CANCELLOUS BONE SCREWS BONE SCREWS HWC AESCULAP, AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other