FDA Adverse Event Injury Summary report: N

INFUSE

MDR report key: 2202111 · Received August 4, 2011

Report

Report Number
MW5021675
Event Type
Injury
Date Received
August 4, 2011
Date of Event
February 19, 2010
Report Date
August 4, 2011
Manufacturer
MEDTRONIC
Product Code
NEK
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
SC, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD A POSTERIOR LUMBAR FUSION AT L5-S1. THE SPINE SURGEON USED BONE MORPHOGENETIC PROTEIN (BMP). SOON AFTER THE FUSION I HAD ACUTE INFLAMMATION IN CENTER OF LOW BACK. SEVERAL MONTHS LATER I HAD THROBBING PAIN GOING DOWN RIGHT LEG (PAIN BEFORE SURGERY INVOLVED THE LEFT BUTTOCK). AN MRI IN (B)(6) 2010 SHOW UNUSUAL CHANGES IN L4 VERTEBRA AND PSOAS MUSCLE. A BIOPSY WAS DONE WHICH SHOWED ACUTE INFLAMMATION. AFTER ANOTHER MRI IN (B)(6) 2010 I WAS REFERRED TO A NEUROSURGEON WHO WAS UNSURE WHAT THE PROBLEM WAS. AFTER ANOTHER MRI IN (B)(6) OF 2011 WHICH SHOWED LARGE OSTEOPHYTES GROWING AND THE L5 NERVE ROOT ENCAPSULATED IN OSTEOPHYTES ANOTHER BIOPSY WAS PERFORMED. IT SHOWED ACUTE INFLAMMATION AND THIS SPINE SURGEON WASN'T SURE WHAT WAS CAUSING THE PROBLEM BUT THOUGHT THAT MAYBE A FUSION AT L4-L5 MIGHT HELP MY PAIN. I THEN SAW A THIRD SPINE SURGEON WHO THOUGHT REMOVING THE SCREWS AND RODS FROM THE FUSION MIGHT HELP WITH THE INFLAMMATION. THEN MY EMPLOYER PAID FOR ME TO HAVE AN EVALUATION DONE AT THE (B)(6) CLINIC. THEY ASKED FOR ALL RECORDS...INCLUDING THE OPERATIVE REPORT WHICH SHOWED BMP WAS USED IN THE FUSION, I DIDN'T EVEN KNOW THE SURGEON WAS USING BMP, BUT JUST THOUGHT MY OWN BONE WOULD CAUSE THE FUSION. THE REPORT CAME BACK THAT THE COMPLICATIONS WERE MOST LIKELY BECAUSE OF THE BONE MORPHOGENETIC PROTEIN USED IN THE FUSION. I HAVE READ THAT BMP CAN LEAK OUT AND CAUSE ACUTE INFLAMMATION, BACK PAIN, UNWANTED BONE GROWTH (THE OSTEOPHYTES) AND RADICULAR LEG PAIN, ALL OF WHICH I AM HAVING. I HAVE READ THAT THE BONE MORPHOGENETIC PROTEIN (BMP) IS NOT APPROVED BY THE FDA TO USE IN A POSTERIOR LUMBAR FUSION. MY PAIN SPECIALIST THINKS THE LARGE OSTEOPHYTES ARE PRESSING ON NERVES AND CAUSING THE PAIN. I AM IN TREMENDOUS PAIN WHEN I SIT OR LIE ON MY BACK. I HAVE BEEN DOING A LOT OF RESEARCH TO FIND A SPINE SURGEON I CAN TRUST AND WHO HAS EXPERIENCE IN COMPLICATIONS WITH BMP. I AM GOING TO SEE THIS SURGEON ON (B)(6), 2011 AND WOULD LIKE TO WRITE BACK TO YOU AFTER MY VISIT TO REPORT ON HIS EVALUATION. I FEEL LIKE THERE ARE MANY PEOPLE WHO HAVE PROBABLY HAD SPINE FUSIONS AND DON'T KNOW WHY THEY ARE HAVING MORE PAIN NOW THAN BEFORE THE SURGERY, ESPECIALLY SINCE I SAW THREE SPINE SURGEONS, 3 MRIS, 3 CT SCANS, 2 BIOPSIES AND NOT ONE OF THE SPINE SURGEONS SAID THEY KNEW WHAT WAS CAUSING THE PROBLEM UNTIL I HAD THE EVALUATION AT THE (B)(6) CLINIC. HOW ARE WE GOING TO FIND ALL THESE PEOPLE WHO HAVE HAD SPINE SURGERIES AND WHO ARE NOW HAVING COMPLICATIONS FROM BMP? I WANT TO HELP THE FDA HELP THESE PEOPLE. PLEASE TELL ME WHAT I CAN DO TO HELP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 INFUSE BONE MORPHOGENETIC PROTEIN LARGE NEK MEDTRONIC

Patients

Seq Age Sex Outcome Treatment
1 66 YR Other