BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CFLEX POLAR HD POS DEVICE ONLY

    MDR report key: 19850694 · Received July 29, 2024

    Report

    Report Number
    3010216206-2024-00008
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    July 8, 2024
    Report Date
    September 13, 2024
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE C-FLEX HEAD POSITIONING SYSTEM CAN BE USED IN ALL TYPES OF SPINAL SURGERY, GIVING SURGEONS AND ANESTHESIOLOGISTS PRECISE CONTROL OVER THE HEAD AND CERVICAL SPINE. THE SQUEEZE AND POSITION TECHNOLOGY SUPPORTS EXACT SET UP AND READJUSTMENTS INTRAOPERATIVELY. VERSATILITY IS PROVIDED BY THE ABILITY TO USE THE SYSTEM WITH HEADRESTS OR WITH SKULL CLAMPS, THE QUICK-CONNECT COUPLER MAKING CONNECTING TO A SKULL CLAMP QUICK AND EASY. AN EXTENSIVE RANGE OF MOTION MAKES THE C-FLEX SYSTEM IDEAL FOR USE WITH EXTREMELY KYPHOTIC PATIENTS, ANTERIOR ARTIFICIAL DISCS AND LATERAL PROCEDURES. UPON INSPECTION, BAXTER TECHNICIAN FOUND THAT THE JOINTS COVER WERE TORN AND THE JOINTS WERE SLIGHTLY LOOSE. A REPLACEMENT OF THE C-FLEX SHOULDER JOINT WAS SENT TO THE CUSTOMER. BASED ON THIS INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF AN UNINTENDED MOVEMENT OF THE HEAD POSITIONING WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.

    Additional Manufacturer Narrative · 0

    BAXTER IS IN THE PROCESS OF INSPECTING THE C-FLEX POLAR HEAD POSITIONER. THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY OR DEATH REPORTED FROM THIS ALLEGED INCIDENT. INVESTIGATION IS ONGOING. ALL ADDITIONAL AND RELEVANT INFORMATION THAT IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION WILL BE SUBMITTED IN A FINAL REPORT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE HEAD POSITIONING PART COULD BE MOVED WITHOUT RELEASING THE BRAKES. THERE WAS NO PATIENT INJURY AND THERE WAS NO PROCEDURAL DELAY REPORTED WITH THIS COMPLAINT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE HEAD POSITIONING PART COULD BE MOVED WITHOUT RELEASING THE BRAKES. THERE WAS NO PATIENT INJURY AND THERE WAS NO PROCEDURAL DELAY REPORTED WITH THIS COMPLAINT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994172 CFLEX POLAR HD POS DEVICE ONLY C-FLEX HEAD POSITIONING SYSTEM CCX ALLEN MEDICAL SYSTEMS A-70701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown