BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-FLEX POLAR HEAD POSITIONER

    MDR report key: 3027605 · Received March 22, 2013

    Report

    Report Number
    1221538-2013-00006
    Event Type
    Other
    Date Received
    March 22, 2013
    Report Date
    February 24, 2013
    Manufacturer
    ALLEN MEDICAL
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOVEMENT WAS NOTED DURING THE STAFF'S SECOND USE, THE REPORTER STATED. THE FIRST CASE, IN WHICH NO MOVEMENT WAS NOTED WAS A LUMBAR SPINE SURGERY. THE REPORTER WAS UNSURE HOW MUCH DOWNWARD PRESSURE WAS BEING APPLIED BY THE SURGEON DURING DRILLING IN THE POSTER CERVICAL CASE, WHEN THE MOVEMENT WAS DETECTED. IN SUBSEQUENT COMMUNICATIONS THE REPORTER HAS DESCRIBED THE MOVEMENT AS "SLIGHT" AND RE-CONFIRMED THERE WAS NO IMPACT TO THE CASE. THE PRODUCT WILL BE EVALUATED UPON RETURN AND A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A REPRESENTATIVE FOR ALLEN MEDICAL'S DISTRIBUTOR IN (B)(6) CONTACTED US FOLLOWING A PATIENT CASE IN WHICH MOVEMENT WAS DETECTED DURING THE USE OF A C-FLEX HEAD POSITIONER. THE DISTRIBUTOR REPORTED THAT DURING A POSTERIOR CERVICAL SPINE CASE, THE ARMS OF THE C-FLEX DROPPED AROUND 3-5MM DURING DRILLING. THERE WAS NO IMPACT TO THE CASE AND NO INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ALLEN REQUESTED THAT THE DEVICE BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120772 C-FLEX POLAR HEAD POSITIONER C-FLEX, SURGICAL HEAD POSITIONER FWZ ALLEN MEDICAL A-70701-A3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA