BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-FLEX POLAR HEAD POSITIONER

    MDR report key: 2132742 · Received June 10, 2011

    Report

    Report Number
    1221538-2011-00011
    Event Type
    Other
    Date Received
    June 10, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    CCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE C-FLEX HEAD POSITIONER WAS RETURNED AND EVALUATED BY AN ENGINEER AND A REPAIR TECH. THE UNIT PERFORMED ALL TESTS ACCORDING TO SPECIFICATION AND NO ISSUES WITH FUNCTION OR SAFETY WERE FOUND. THE REPORT OF PERCEIVED MOVEMENT COULD NOT BE VERIFIED. THESE RESULTS WERE COMMUNICATED BACK TO THE REPORTER.

    Description of Event or Problem · 1

    AN ALLEN SALES REP WAS CONTACTED ON (B)(6) WITH THE REPORT THAT THE C-FLEX HEAD POSITIONER DEMO USED IN A SPINAL CASE "APPEARED TO HAVE MOVED ABOUT 5 DEGREES" OVER THE COURSE OF THE CASE. OTHER THAN THIS OBSERVATION, THERE WAS NO IMPACT OR DELAY AND THERE WERE NO INJURIES TO THE PT. THE FAILURE COULD NOT BE REPLICATED IN THE FIELD FOLLOWING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-FLEX POLAR HEAD POSITIONER HEAD POSITIONER CCX ALLEN MEDICAL SYSTEMS A-70700-A1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA