PYRAMESH IMPLANT SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2004, THE PATIENT PRESENTED WITH CHIEF COMPLAINT OF EXCRUCIATING PERSISTENT LOW BACK PAIN WITH RADIATION TO THE LEFT BUTTOCK AND LEFT LOWER EXTREMITY. THE PATIENT REPORTED THE PAIN AS 8 ON SCALE FROM 0 TO 10. THE PAIN STARTED TWO MONTHS PRIOR AFTER OBTAINING PHYSICAL THERAPY FOR A JOB RELATED INJURY ON (B)(6) 2003. AP AND LATERAL FLEXION/EXTENSION X-RAYS OF THE LUMBAR SPINE REVEALED SIGNS OF SEVERE SPINAL INSTABILITY, SPONDYLOLISTHESIS AT L5-S1, AND RADICULOPATHY WITHIN THE L5-S1 DISTRIBUTION ON THE LEFT. THE CONDITION WAS NOTED TO BE CHRONIC IN NATURE AND AGGRAVATED BY THE PATIENT¿S LOWER EXTREMITY CONDITION. PER THE MEDICAL RECORDS, THE PATIENT WAS TOTALLY DISABLED AND WAS TAKING VICODIN FOR PAIN CONTROL. AT A (B)(6) 2004 OFFICE VISIT, THE PATIENT RETURNED TO DISCUSS THE RESULTS OF AN MRI AND CT SCAN OF THE LUMBAR SPINE. CLINICALLY, THE PATIENT CONTINUED TO COMPLAIN OF AGONIZING LOW BACK PAIN REQUIRING PERCOCET AND VICODIN FOR THE PAIN. SHE BARELY COULD STAND, SIT OR WALK FOR EVEN A SHORT PERIOD OF TIME. IMPRESSION WAS HERNIATION OF NUCLEUS PULPOSUS AT L4-5 AND L5-S1, DISCOGENIC LOW BACK PAIN, POSTERIOR ANNULUS TEAR AT L4-5 AND L5-S1, SEGMENTAL SPINAL INSTABILITY AT L5-S1, SPONDYLOLISTHESIS AT L5-S1. THE PATIENT¿S CURRENT CONDITION WAS NOTED TO BE CAUSALLY RELATED TO THE INJURY SUSTAINED AT WORK. RECOMMENDATION WAS FOR STABILIZATION SPINAL SURGERY, POSTERIOR SPINAL FUSION AT L4-5 AND L5-S1. ON (B)(6) 2004, THE PATIENT UNDERWENT RETROPERITONEAL APPROACH TO THE LUMBAR SPINE ON THE LEFT; ANTERIOR LUMBAR DISCECTOMY AND FUSION AT L4-L5, ARTHRODESIS; ANTERIOR CERVICAL DISCECTOMY AND FUSION AT L5-S1, ARTHRODESIS, ADDITIONAL LEVEL; PLACEMENT OF INTERVERTEBRAL CAGES AT L4-L5 AND L5-S1 INTERSPACES; ALLOGRAFT, MORSELLIZED FOR THE SPINAL SURGERY AND REMAINING CAVITIES AROUND THE CAGES WERE FILLED WITH THE COLLAGEN MATRIX, HALOS. THE SURGERY WAS WITHOUT COMPLICATIONS. POSTOPERATIVE DIAGNOSES INCLUDED DISKOGENIC LOW-BACK PAIN AND HERNIATION OF NUCLEUS PULPOSUS AT L4-L5 AND L5-S1; POSTERIOR ANNULAR TEAR AT L4-L5 AND L5-S1; DEGENERATIVE FACET DISEASE AT L5-S1 WITH DEGENERATIVE SPONDYLOLISTHESIS AT L5-S1; SEGMENTAL SPINAL INSTABILITY AT L5-S1. ON (B)(6) 2005, TWO MONTHS POST-SURGERY, THE PATIENT WAS DOING WELL AND X-RAYS DEMONSTRATED INTACT HARDWARE WITH A LARGE AMOUNT OF FUSION/GRAFT MASSES POSTEROLATERALLY. SHE WAS TO START PHYSICAL THERAPY AND WAS ADVISED TO TAKE PERCOCET ON AN AS NEEDED BASIS ONLY. ON (B)(6) 2005, THE PATIENT STILL HAD MECHANICAL BACK PAIN WHICH SHE CONTROLLED WITH OCCASIONAL PERCOCET. X-RAYS OF THE LUMBAR SPINE DEMONSTRATED FORMING L4 TO THE SACRUM CIRCUMFERENTIAL FUSION WITH INTACT HARDWARE; THERE WERE NOTICEABLE POSTEROLATERAL GRAFT/FUSION MASSES. ON (B)(6) 2005, X-RAYS OF THE LUMBAR SPINE FAILED TO DEMONSTRATE ANY PROBLEM; THE FUSION WAS SOLID AND FORMING IN THE RIGHT PERSPECTIVE; THERE WAS NO CHANGE IN POSITION OF THE HARDWARE. ON (B)(6) 2005, FIVE MONTHS POST-SURGERY, THE PATIENT CONTINUED TO COMPLAIN OF PAIN IN THE MIDDLE PORTION OF HER LUMBOSACRAL AREA, AS WELL AS RIGHT SIDED PAIN OCCASIONALLY RADIATING TO BOTH LOWER EXTREMITIES. AT THE SEVEN MONTH FOLLOW-UP VISIT ON (B)(6) 2005, THE PATIENT CONTINUED TO BE IN PAIN, WHICH RADIATED INTO THE POSTERIOR BUTTOCKS AND OCCASIONALLY TO THE LEGS; IT HAD BEEN GETTING WORSE SINCE LAST VISIT. X-RAYS OF THE LUMBAR SPINE SHOWED NO NOTICEABLE SIGNS OF THE FAILURE OF FUSION. IN (B)(6) 2005, A CT SCAN OF THE LUMBAR SPINE SHOWED NO SIGNS OF MALPOSITION OF THE HARDWARE OR DISLODGEMENT; THERE WAS NOTICEABLE INSUFFICIENCY AT THE FUSION MASSES PARTICULARLY ON THE RIGHT SIDE WITH THE INCOMPLETE TRANSVERSE LUCENT LINE ACROSS THE FUSION MASSES AT L5-S1 INTERSPACE WITH THE NOTICEABLE VACUUM PHENOMENON WITHIN THE REMAINING FACETS; THE REST OF THE FUSION MASSES WERE QUITE IRREGULAR WITH THE PATCHY APPEARANCE. THE PATIENT WAS ADVISED TO STOP AGGRESSIVE PHYSICAL THERAPY AND SWITCH TO AQUA THERAPY; SHE WAS ALSO ADVISED AGAIN ABOUT THE NEGATIVE EFFECT OF TOBACCO SMOKING UPON THE FUSION PROCESS. IT WAS NOTED SHE CLEARLY UNDERSTOOD EVERYTHING. IN (B)(6) 2005, A CT SCAN OF THE LUMBAR SPINE SHOWED INTACT HARDWARE WITH MINIMAL ELEMENTS OF THE LOOSENING AROUND THE PEDICLE SCREWS; ALL SCREWS WERE WITHIN ANATOMICAL BOUNDARIES; THERE WAS SOME INCORPORATION OF THE CAGES ANTERIORLY WITHOUT SIGNS OF RESORPTION; THERE WERE QUESTIONABLE AREAS OF THE FUSION AT THE POSTEROLATERAL AREAS, PARTICULARLY AT L5-S1 ON THE RIGHT, WHICH COULD REPRESENT THE DELAYED FUSION. ON (B)(6) 2006, THE PATIENT CONTINUED TO COMPLAIN OF SEVERE LOW BACK PAIN WITH THE SENSATION OF BOTH LEGS BEING NUMB AND TINGLING. MULTIPLE CONSULTS WITH OTHER PRACTITIONERS IN THE PREVIOUS MONTHS REVEALED A GENERAL CONSENSUS THAT THE PATIENT¿S SITUATION WAS SOLID AND THE MAJORITY OF SYMPTOMS WERE RELATED TO EITHER WHAT WAS CALLED FACET IMPINGEMENT OR SCAR TISSUE PHENOMENON. X-RAYS SHOWED SOLID L4-L5 AND L5-S1 FUSION WITHOUT SIGNS OF THE RESORPTION AROUND THE HARDWARE. IT WAS MORE THAN A YEAR AFTER THE SURGERY AND AT THIS POINT IF THE FUSION HAD FAILED SOME RESORPTION AROUND THE HARDWARE WOULD BE EXPECTED; IT WAS ASSUMED THE EFFUSION WAS WELL FORMED. AT THIS TIME, THE PATIENT ELECTED FOR REMOVAL OF THE HARDWARE. ON (B)(6) 2006, THE PATIENT WAS HOSPITALIZED WITH DIAGNOSIS OF FAILED BACK SYNDROME, MECHANICAL FAILURE OF HARDWARE AND LOW BACK PAIN. AT THAT TIME, SHE UNDERWENT EXPLORATION OF L4-5 AND L5-S1 FUSION; REMOVAL OF SEGMENTAL PEDICLE HARDWARE AT L4-5 AND L5-S1 INTERSPACES; POSTEROLATERAL REVISION OF SPINAL FUSION AT L4-5, ARTHRODESIS; POSTEROLATERAL FUSION AT L5-S1, ARTHRODESIS, REVISION FUSION, ADDITIONAL LEVEL; FOUR STRIPS OF RHBMP-2/ACS WERE PLACED ON TOP OF THE DECORTICATED BONY STRUCTURES AT L4-5, L5-S1 INTERSPACES FOR THE SPINAL FUSION, ALLOGRAFT, MORSELLIZED FOR THE SPINAL SURGERY. THERE WERE NO COMPLICATIONS. POSTOPERATIVE DIAGNOSES INCLUDED INSUFFICIENT FUSION AT L4-5 AND L5-S1, MECHANICAL LOOSENING OF THE PEDICLE HARDWARE AT S1 AND L4 LEVELS, LOW BACK PAIN. AT POST-SURGERY OFFICE VISITS IN (B)(6) 2006, THE PATIENT CONTINUED TO COMPLAIN OF LOW BACK PAIN. IMPRESSION REMAINED THE SAME: FAILED BACK SYNDROME, STATUS POST L4 TO S1 FUSION WHICH RESULTED IN THE SUCCESSFUL RADIOLOGICAL FUSION BUT DID NOT PROVIDE THE PATIENT WITH THE CLINICAL POSITIVE OUTCOME. AT AN OFFICE VISIT ON (B)(6) 2006, THE PATIENT CONTINUED TO COMPLAIN OF NARCOTIC-DEPENDENT LOW BACK PAIN WITH PAIN RADIATING TO THE RIGHT LOWER EXTREMITY. IT WAS ASSOCIATED WITH TINGLING AND NUMBNESS IN THE RIGHT LEG AS WELL AS DIFFICULTY MAINTAINING UPRIGHT AND SITTING POSITION FOR LONGER THAN HALF AN HOUR. SHE WAS ATTENDING PHYSICAL THERAPY AND WAS TAKING AVINZA DAILY AS WELL AS OXYCODONE FOR BREAKTHROUGH PAIN. SHE ADMITTED TO SOME IMPROVEMENT IN HER BACK PAIN AFTER THE SURGERY BUT IT WAS NOT TO THE DEGREE WHERE SHE WOULD BE ABLE TO ENJOY INDEPENDENT WALKING, SITTING, AND PROLONGED STANDING.

Additional Manufacturer Narrative

(B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.