BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYPE-S HEAD EXTENSION

    MDR report key: 910968 · Received September 8, 2007

    Report

    Report Number
    1932738-2007-00002
    Event Type
    Malfunction
    Date Received
    September 8, 2007
    Report Date
    August 9, 2007
    Manufacturer
    MED-TEC INC. (DBA CIVCO MEDICAL SOLUTIONS)
    Product Code
    JAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DESIGNED WITH EPOXY HOLDING TOGETHER THE SUPPORTS FOR THE DEVICE. THE STRENGTH OF THE EPOXY CAN DECREASE WHEN SUBJECTED TO IMPACT LOADS CAUSED BY COLLISIONS OR IMPROPER HANDLING. THE DEVICE HAD IMPACT MARKERS POSSIBLE FROM PREVIOUS IMPROPER HANDLING. OVER TIME THE STRENGTH CAN DECREASE ENOUGH FOR FAILURE TO OCCUR. ADDITIONAL INFORMATION ABOUT USE OF PRODUCT DURING FAILURE OR DETAILS ABOUT INJURIES WERE NOT KNOWN BY DISTRIBUTOR. PATIENT INFORMATION WAS NOT PROVIDED BY THE DISTRIBUTOR. INSTRUCTIONS FOR USE DESCRIBES AND DIAGRAMS CORRECT REPOSITIONING PROCESS OF PATIENT/CLINICIAN. INSTRUCTIONS FOR USE INDICATES TO INSPECT FOR DAMAGE/WEAR PRIOR TO USE AND NOT TO USE A DAMAGED DEVICE. ADVERSE EVENT OCCURRED IN ANOTHER COUNTRY. ADDITIONAL CONTACT INFORMATION WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    CIVCO WAS NOTIFIED THAT A TYPE-S HEAD EXTENSION JOINTS UNSTUCK WHEN THE PATIENT'S BODY WAS ON THE COUCH AT THE HEAD EXTENSION WHEN THE PATIENT FELL AND WAS INJURED ON THE ELBOW. PATIENT DISCOMFORT BUT NO SERIOUS OUTCOME WAS ATTRIBUTED TO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYPE-S HEAD EXTENSION CARBON FIBER COUCH INSERT JAI MED-TEC INC. (DBA CIVCO MEDICAL SOLUTIONS) 20-CFHN-SUB2-V NA

    Patients

    Seq Age Sex Outcome Treatment
    1