Description of Event or Problem · 1
IN (B)(6) 2004, DR. (B)(6) INSTALLED THE FOLLOWING ITEMS IN MY BACK: 498.751,498.570, 498.505,498.503 & 498.142 THESE ARE THEIR NUMBERS. I FELL IN A HOTEL IN (B)(6) OF 2009 DUE TO A FAULTY PIECE OF EQUIPMENT. IN THE FALL THE CHAIR THAT WAS NEGLIGENT BROKE ONE OF THE SCREWS IN MY BACK WITH THE 6 TITANIUM RODS THAT WERE INSERTED (SEE NUMBERS ABOVE). DR. (B)(6) REQUEST THAT I FIND OUT THE COMPANY NAME OF THE HARDWARE IN MY BACK AND CALL FOR A SAMPLE SO THAT THE ALLERGIST CAN TEST TO SEE IF I AM ALLERGIC BECAUSE I AM HAVING BREAK OUTS. FIVE DOCTORS, MY HUSBAND, AND I HAVE CALLED THIS COMPANY AND WE ALL GET RE-ROUTED TO (B)(6). SHE SENT AN E-MAIL TO ME STATING THAT MY ALLERGIST WOULD BE ABLE TO TEST ME WITH THIS E-MAIL OF BREAK DOWN "PRODUCT LIABILITY" DEPARTMENT. I SHOWED OUR ALLERGIST, AND HE THOUGHT SHE WAS NUTS. MY HUSBAND CALLED THE CEO'S OFFICE, AND TALKED WITH HIS ASSISTANT THAT WOULD PUT ME IN TOUCH WITH (B)(6). HE AT FIRST ON (B)(6) 2011 SAID NO PROBLEM, I WILL GET TO THE BOTTOM OF THIS, AND GET YOU A SAMPLE "WE ARE IN THE BUSINESS OF HELPING PEOPLE NOT MAKING THEM SUFFER." THAT WAS A JOKE. HE THEN CALLED ME AND ADVISED ME THAT (B)(6) ADVISED HIM THAT THE FDA DOES NOT ALLOW THEM TO SEND SAMPLES BECAUSE THE FDA REGULATES THEM AND THEY ARE NOT "ALLOWED" TO SEND SAMPLES OUT. HE ADVISED ME THAT (B)(6) WOULD CONTACT MY ALLERGIST DR. (B)(6). AS OF THIS COMPLAINT, HE HAS NOT. I HAVE SPOKEN TO THE FDA AND THEY DO REGULATE SYNTHES BUT IN NO WAY SHAPE OR FORM ADVISED THEM THEY ARE NOT ALLOWED TO SEND OUT SAMPLES, OTHER HARDWARE COMPANIES DO. I SPOKE WITH (B)(6) FROM THE FDA. SHE IS FROM THE (B)(6) DISTRICT OFFICE OF THE FDA. I HAVE ALSO CONTACTED THE MAIN FDA OFFICE. I CALLED SYNTHES TODAY AND SPOKE WITH A (B)(6) IN THE CFO OFFICE. WAITING FOR AN ANSWER. LEFT A MESSAGE WITH (B)(6). HE IS OUT TILL THE (B)(6) (WILL ADVISE IF HE CALLS ME BACK). I DID CALL AND SCREAM AT (B)(6) TODAY, BUT I HAVE HAD IT. I NEED THIS TO GET MY BACK CORRECTED. THEY ARE HINDERING THE ABILITY OF ME GETTING MY SPINE CORRECTED. WITH ALL THIS HUSH HUSH AND TRANSFER, A QUESTION ARISES - IS THERE SOMETHING WRONG WITH MY HARDWARE THAT THEY ARE HIDING? THIS IS A VERY SIMPLE TASK AS EVERY OTHER HARDWARE COMPANY SENDS SAMPLES EVERY DAY AS I HELPED MY ALLERGIST GO THROUGH A BOX OF ABOUT 75 DIFFERENT PIECES OF HARDWARE FROM DIFFERENT COMPANIES. PLEASE CALL ME OR MY HUSBAND FOR A FULL EXPLANATION. WE SPOKE WITH (B)(6), WAS EXTREMELY HELPFUL. (B)(6). THANK YOU IN ADVANCE FOR YOUR HELP.