BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYPE-S HEAD EXTENSION

    MDR report key: 950580 · Received April 20, 2007

    Report

    Report Number
    1932738-2007-00001
    Event Type
    Malfunction
    Date Received
    April 20, 2007
    Date of Event
    March 26, 2007
    Report Date
    April 11, 2007
    Manufacturer
    CIVCO MEDICAL SOLUTIONS, MED-TEC INC.
    Product Code
    IWY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICIAN/HOSPITAL GLUED JOINT TOGETHER PRIOR TO RETURNING FOR EVALUATION WHICH MADE EVALUATION OF THE ORIGINAL JOINT ADHESIVE IMPOSSIBLE. PATIENT REPOSITIONED SELF PUTTING EXCESSIVE PRESSURE ON WORN DEVICE. INSTRUCTIONS FOR USE DESCRIBES AND DIAGRAMS CORRECT REPOSITIONING PROCESS OF PATIENT/CLINICIAN. INSTRUCTIONS FOR USE INDICATE TO INSPECT FOR DAMAGE/WEAR PRIOR TO USE AND NOT TO USE A DAMAGED DEVICE.

    Description of Event or Problem · 1

    CIVCO WAS NOTIFIED THAT A TYPE-S HEAD EXTENSION JOINT BROKE NEAR THE LOCKING MECHANISM AND ALLOWED THE PATIENT TO FALL. THE PATIENT WAS LYING FLAT ON THEIR BACK AS THEY ADJUSTED THEMSLEF OF THE TYPE-S HEAD EXTENSION. THE TYPE-S HEAD EXTENSION BROKE AND THE PATIENT FELL ABOUT 2-3 FEET. THE PATIENT WAS EVALUATED BY X-RAY AND NO INJURY WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYPE-S HEAD EXTENSION CARBON FIBER COUCH INSERT IWY CIVCO MEDICAL SOLUTIONS, MED-TEC INC. 20-CFHN-SUB2-V 2901

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other