POLARIS 5.5 TI 60MM TI CURVED ROD

Additional Manufacturer Narrative

THE IMPLANTS ARE TITANIUM ALLOY. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REPORT FIVE OF FIVE FOR THE SAME EVENT; SEE ALSO 3004485144-2016-00054 THROUGH 00057. REMAINS IMPLANTED.

Description of Event or Problem

THE SALES ASSOCIATE REPORTED THAT A PATIENT UNDERWENT A SURGERY IN 2012 IN WHICH A POLARIS WAS IMPLANTED. AN ALLERGY TO SOME COMPONENTS SUCH AS COBALT CHLORIDE, GOLDEN SODIUM BISULFITE AND NICKEL HAS BEEN DETECTED TO THE PATIENT. IT IS REPORTED NO REVISION SURGERY IS PLANNED AT THIS TIME AND THE SURGEON DOES NOT THINK THE PATIENT'S SYMPTOMS ARE RELATED TO THE IMPLANTS.