C-FLEX POLAR HEAD POSITNER- DEVICE ONLY

Additional Manufacturer Narrative

THE HEAD POSITIONER IS DESIGNED TO POSITION AND SUPPORT THE PATIENT¿S HEAD IN A VARIETY OF SURGICAL PROCEDURES INCLUDING, BUT NOT LIMITED TO SPINE SURGERY. THESE DEVICES ARE INTENDED TO BE USED BY HEALTHCARE PROFESSIONALS WITHIN THE OPERATING ROOM SETTING. BASED ON SERIAL NUMBER INFORMATION PROVIDED, BAXTER MEDICAL DEVICE REFERENCED IN THIS REPORT WAS MANUFACTURED IN 2012, MAKING IT OVER 10 YEARS OLD. THE DEVICE HAS REACHED THE END OF ITS USEFUL LIFE, MAKING IT INELIGIBLE FOR REPAIR. BAXTER SALES REPRESENTATIVE PROVIDED ASSISTANCE TO THE ACCOUNT FOR A REPLACEMENT PURCHASE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF C-FLEX HEAD POSITIONER NOT HOLDING WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE, BAXTER IS REPORTING THIS EVENT.

Description of Event or Problem

BAXTER RECEIVED A REPORT STATING THAT CFLEX POLAR HEAD POSITIONER KNOB THAT LOCK HORIZONTAL TRANSLATION ARE STUCK AND THE C-FLEX SLIDES FREELY. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED.