Description of Event or Problem · 1
(B)(6) 2007 PT HAD OFF-LABEL 2-LEVEL L4-5, L5-S1 POSTERIOR LUMBAR FUSION SURGERY USING INFUSE BONE GRAFT (PMA 000058) IN COMBINATION VERTE-STACK CAPSTONE PEEK (SPACER) SPINAL SYSTEM (510 (K) K073291), MASTER GRAFT MATRIX, TISSEEL ROD FIXATION INSTRUMENTATION AND DURAGEN GRAFT MATRIX. SURGEONS DID NOT INFORM PT THAT VERSTACK PEEK SPACER DID NOT YET HAVE FDA CLEARANCE OR THAT MEDTRONIC REPRESENTATIVES WOULD BE PRESENT DURING OPERATIVE PROCEDURE OR THAT SURGEONS HAD FINANCIAL INTERESTS AND TIES TO MEDTRONIC. PT DEVELOPED SEVERE POST-OPERATIVE PAIN IN BACK AND LEG. CAPSTONE SPACER, UNDER RADIOGRAPH, WAS OBSERVED TO HAVE MIGRATED POST-OPERATIVELY OUT OF DISK SPACE L4-5 POSTERIORLY ENCROACHING ON SPINAL CORD. (B)(6) 2008 CAPSTONE DEVICE WAS EXPLANTED VIA LATERAL APPROACH. PT HAS PRESERVED EXPLANTED CAPSTONE. ANOTHER SPACER UNKNOWN ORIGIN WAS IMPLANTED BY ORIGINAL SURGEONS IN COMBINATION WITH SMALL INFUSE BONE GRAFT KIT AND 20CC KIT OF MASTERGRAFT MATRIX AND AN UNKNOWN MODEL/VERSION OF NUVASIVE PLM ANTERIOR PLATE, THOUGH THE LATER DEVICE WAS NOT RECORDED INTO THE DEVICE IMPLANT RECORDS AND LIKELY DID NOT HAVE 510 (K) APPROVAL. PT DEVELOPED SEVERE ACNE CYST NEAR THE SURGICAL SITE 2-3 WEEKS POST-OPERATIVELY. PATHOLOGY TEST REVEALED ABNORMAL HORMONAL LEVELS, EVENTUALLY LEADING TO PT HAVING OOPHORECTOMY OF OVARIES FOR BENIGN OVARIAN CYST (S). PT BACK AND LEG PAIN CONTINUED TO GROW IN SEVERITY NECESSITATING IMPLANTATION OF A FIRST ANS PAIN STIMULATOR, FOLLOWED BY A SECOND ANS PAIN STIMULATOR. (B)(6) 2012 MRI SPINE REVEALS ECTOPIC BONE GROWTH ENCROACHING ON L4-5 NERVE ROOT.