CFLEX POLAR HD POS DEVICE ONLY
Received Jul 29, 2024 · Event occurred Jul 8, 2024
Report 3010216206-2024-00008 · MDR key 19850694
Device
Product problems
- Positioning Failure
- Unintended Movement
- Positioning Failure
- Unintended Movement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
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).
Additional Manufacturer Narrative
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
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).