INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2015-02076
- Event Type
- Injury
- Date Received
- August 25, 2015
- Report Date
- July 27, 2015
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
(B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
IT WAS REPORTED THAT ON : (B)(6) : FOLLOWING DIAGNOSIS ARE REPORTED -BIPOLAR DISORDER, CHRONIC PAIN , DIABETES , MENTAL ILLNESS (B)(6) :PATIENT WAS DIAGNOSED FOR MAJOR DEPRESSION AND SCHICO EFFECTIVE DISORDER (B)(6) 2006 , PATIENT PRESENTED WITH RIGHT ANKLE WOUND TREATMENT. (B)(6) 2006 , PATIENT WAS DIAGNOSED FOR MAJOR DEPRESSION AND SUICIDAL IDEATION (B)(6) 2007 , THE PATIENT PRESENTED WITH COMPLEX NON-HEALING WOUND OF RIGHT ANKLE. FOLLOWING PROCEDURE WAS PERFORMED - A SPLIT-THICKNESS SKIN GRAFT WAS HARVESTED .011-INCH THICK FROM THE RIGHT THIGH. THE GRAFT WAS MIXED 1.5:1 ON THE MESHER AND SUTURED INTO PLACE IN THE 2 CREVICES AT THE SUPERIOR AND INFERIOR ENDS OF THE PREVIOUS WOUND. THE GRAFTS WERE COVERED WITH BACITRACIN OINTMENT, TELFA, 4X4S, KERLIX ROLL, AND ACE WRAP . 18 MAY 2007, PATIENT PRESENTED WITH LUMBAR RADICULOPATHY AND UNDERWENT FOLLOWING PROCEDURE - RIGHT L4 TRANSFORAMINAL EPIDURAL STEROID INJECTION WITH FLUOROSCOPY. (B)(6) 2007 , THE PATIENT PRESENTED WITH LEG WOUND. (B)(6) 2007 , THE PATIENT PRESENTED FOR CONSULTATION RELATED TO CURRENT AILMENTS. X RAYS / ECG WERE NORMAL. (B)(6) 2007 , THE PATIENT VISITED FOR EVALUATION OF HER L4-5 DISC DISEASE. (B)(6) 2007 , THE PATIENT PRESENTED WITH FOLLOWING PREOPERATIVE DIAGNOSIS : DEGENERATIVE DISC DISEASE, L4-L5 LEVEL WITH MODIC END -PLATE CHANGES L4-L5 LEVEL. GRADE 0-I RETROLISTHESIS OF L4 ON L5. CENTRAL/RIGHT PARACENTRAL EXTRUDED DISK L4-L5 LEVEL WITH CAUDAL MIGRATION TO BEHIND THE VERTEBRAL BODY OF L5. THE FOLLOWING PROCEDURE WAS PERFORMED : ANTERIOR LUMBAR DISKECTOMY, AND DECOMPRESSION L4-L5 LEVEL, WITH INTERBODY FUSION L4-L5 LEVEL USING PEEK (POLYETHER-ETHER-KETONE) INTERVERTEBRAL SPACER PACKED WITH BMP (BONE MORPHOGENIC PROTEIN), WITH PLACEMENT OF ANTERIOR PLATE AND SCREWS L4 TO L5 . IT WAS A ALL ANTERIOR TO THE LIGAMENT, AND SURGEON COULD EASILY SCOOP DOWN BEHIND THE VERTEBRAL BODY OF L5 AND CLEAN OUT THE DISC FRAGMENTS. ONCE ALL THE DISC WAS REMOVED, INCLUDING THE DISC FRAGMENTS, THE ENDPLATES WERE CURETTED OF ANY REMAINING CARTILAGE. A TRIAL SPACER WAS PLACED IN THE DISC SPACE, X-RAY WAS TAKEN, AND IT CONFIRMED GOOD SIZING OF THE TRIAL SPACER. THEN A PEEK SPACER PACKED WITH BONE ( MORPHOGENIC PROTEIN WAS THEN PLACED IN THE DISC SPACE OF L4-L5. X-RAY CONFIRMED GOOD POSITION OF THE SPACER. X RAY TEST WERE PERFORMED DURING HER STAY IN HOSPITAL . IMPRESSIONS : POSTFUSION CHANGES AT L4-5. NORMAL CHEST EXAMINATION. (B)(6) 2007 , THE PATIENT PRESENTED FOR FOLLOW-UP POST OP SURGERY. IMPRESSION (XRAY): GOOD INITIAL HEALING OF ANTERIOR FUSION L4-5 WITH 5 BEING A TRANSITIONAL VERTEBRA. (B)(6) 2007, PATIENT PRESENTED FOR ROUTINE FOLLOW-UP POST SURGERY. X RAY CONFIRMED THAT HER ANTERIOR FUSION LOOKS GOOD. PLATE IS IN GOOD POSITION . (B)(6) 2008 , PATIENT PRESENTED FOR ROUTINE FOLLOW-UP POST SURGERY. COMPLAIN OF SOME PAIN. XRAY REVEALED GOOD HEALING . (B)(6) 2008 , PATIENT UNDERWENT MRI . IMPRESSION : THE PATIENT IS STATUS POST ANTERIOR FUSION AT L4-L5 WITH INTERBODY FUSION NOTED ANTERIORLY IN THE DISC SPACE. AT L3-L4, DEGENERATIVE DISC IS SEEN WITH POSTERIOR CENTRAL AND INFERIOR HIGH INTENSITY ZONE CONSISTENT WITH AN ANNULAR TEAR. DEGENERATIVE DISC IS SEEN AT L2-L3 WITHOUT FOCAL DISC PROTRUSION. (B)(6) 2008 , THE PATIENT PRESENTED FOR FLUOROSCOPIC TEST DUE TO LOW BACK PAIN . IMPRESSION: FLUOROSCOPIC-GUIDED EPIDURAL SPINAL INJECTION PERFORMED AS ABOVE. (B)(6) 2008 , THE PATIENT WAS PRESENTED FOR MRI REVIEW . ANNULAR TEAR AT L3-4 LEVEL ABOVE HER FUSION IS NOTED. (B)(6) 2008 , PATIENT VISITED DUE TO BACK PAIN .ANOTHER ANTERIOR FUSION AT L3-4 WAS PLANNED . (B)(6) 2008 , UNDERWENT X RAYS EXAMINATION . IMPRESSION : NEGATIVE CHEST. POSITIVE FOR MUSCULOSKELETAL, HEART DISEASE , INCREASED WEIGHT . (B)(6) 2008 , PATIENT UNDERWENT ANTERIOR LUMBAR DISKECTOMY AND INTERBODY FUSION, L3-L4 LEVEL. USING PEEK INTRAVERTEBRAL SPACER PACKED WITH BMP WITH PLACEMENT OF ANTERIOR PLATE AND SCREW . POST OP X RAY REVEALED SATISFACTORY POSITION AND ALIGNMENT OF THE PEEK SPACER AT LEVEL L3-4 AND ANTERIOR PLATES AND SCREW. SHE WITHSTOOD THE PROCEDURE WELL, HAD AN UNEVENTFUL POSTOPERATIVE HOSPITAL COURSE. SHE WAS NOTED TO HAVE POSTOPERATIVE PARALYTIC ILEUS ON 21 MAR 2008. IMPRESSION : POSTOPERATIVE CHANGES OF THE LOWER LUMBAR SPINE. DEGENERATIVE CHANGES OF THE LOWER LUMBAR SPINE (B)(6) 2008 , (B)(6) 2008 ,(B)(6) 2008 - PATIENT CALLED TO COMPLAIN INCREASED SHARP, GRABBING AND STABBING PAIN AND MUSCLE SPASM IN HER LOW BACK REGION WITH SUBSEQUENT RADIATION OF PAIN INTO HER BUTTOCKS AND DOWN THE BACK OF HER THIGHS TO HER KNEES. (B)(6) 2008 , THE PATIENT PRESENTED WITH BACK AND LEFT LEG PAIN. SHE WAS ADMITTED AND DIAGNOSED WITH MEDICINES TO IMPROVE HER PAIN CONDITION. X RAY IMPRESSION : STABLE ALIGNMENT. ANTERIOR FUSION AT L4-5 AND L3-4 LEVELS. NO ACUTE DISC HERNIATION OR STENOSIS IS SHOWN. CT EXAMINATION IMPRESSION : NO STENOSIS. WELL MAINTAINED ALIGNMENT . ARACHNOIDAL ADHESIONS SHOULD BE CONSIDERED IN THE LOWER LUMBAR SPINE (B)(6) 2008 , PATIENT UNDERWENT ANOTHER X RAY EXAMINATION . IMPRESSION : SUCCESSFUL TRANSFORAMINAL EPIDURAL STEROID INJECTION . (B)(6) 2008 , ANOTHER X RAY WAS PERFORMED. IMPRESSION : INCREASED UPTAKE AT THE LEVEL OF THE L3 VERTEBRAL BODY, POSSIBLY L4 BUT THIS APPEARS TO BE AT L3, OF UNCERTAIN ETIOLOGY, SEEN ONLY ON THE SPECT IMAGING OF THE LUMBAR SPINE. PLAIN FILMS WOULD BE USEFUL. FRACTURE WOULD CERTAINLY HAVE TO BE A CONSIDERATION, THOUGH THIS COULD BE MERELY DEGENERATIVE CHANGE . FINDINGS CONSISTENT WITH OLD HEALED FRACTURE DEFORMITIES INVOLVING THE DISTAL TIBIA AND FIBULA ON THE RIGHT. (B)(6) 2008 - FLUOROSCOPIC TEST . IMPRESSION : STATUS POST FLUOROSCOPIC INJECTION OF THE RIGHT FACET,LEFT FACET. AND TRANSITIONAL ANATOMY AT THE LSSI LEVEL. (B)(6) 2008 , ANOTHER FACET INJECTION WAS REQUESTED BY PATIENT . IMPRESSION : STATUS POST STEROID INJECTION AT THE RIGHT AND LEFT LS-SI FACETS AS WELL AS AT THE POINT OF TRANSITIONAL ANATOMY ON THE LEFT AT L5-S1. (B)(6) 2008, PATIENT PRESENTED FOR FOLLOW-UP . XRAYS PERFORMED . IMPRESSION : HEALED ANTERIOR FUSION L4-5 WITH GOOD INITIAL HEALING OF ANTERIOR FUSION L3- 4 (B)(6) 2008 , THE PATIENT VISITED FOR GENERAL MEDICAL/PREOPERATIVE EVALUATION PRIOR TO ANTERIOR LUMBAR INTERBODY FUSION . (B)(6) 2008, PATIENT PRESENTED WITH LOW BACK PAIN. SHE WAS ADMITTED WITH FOLLOWING PREOPERATIVE DIAGNOSIS : DEGENERATIVE DISK DISEASE L5-SL . THE PATIENT COMPLAINED OF "HAVING CONSTANT SHARP BURNING, STABBING, ACHING PAIN IN THE CENTER OF HER LOW BACK REGION WITH OCCASIONAL PAIN INTO HER LEFT BUTTOCK REGION AND DOWN THE BACK OF HER LEFT THIGH TO HER LEFT KNEE WITH OCCASIONAL NUMBNESS AND TINGLING IN HER LEFT LEG WHEN STANDING AND WALKING, AND MILD WEAKNESS IN HER LEFT LEG WHEN STANDING AND WALKING . PATIENT UNDERWENT XRAYS AND PHYSICAL EXAMINATIONS ON THE SAME DAY. THE FOLLOWING PROCEDURE WAS PERFORMED : ANTERIOR LUMBAR DISKECTOMY AND INTERBODY FUSION L5-S I LEVEL USING PEEK (POLYETHER-ETHER-KETONE) INTERVERTEBRAL SPACER PACKED WITH BMP (BONE MORPHOGENIC PROTEIN) WITH PLACEMENT OF ANTERIOR PLATE AND SCREWS L5 TO S 1. PER OP NOTES , SHE UNDERWENT LAPAROTOMY WITH LEFT PREPERITONEAL OR RETROPERITONEAL EXPOSURE OF THE ANTERIOR LUMBAR SPINE (L5-SL INTERVERTEBRAL DISK SPACE.) DURING THE PROCEDURE , THE DR. THEN MADE A SKIN INCISION IN HER LOWER ABDOMEN BELOW HER UMBILICUS. HE THEN DID THE EXPOSURE AND DID A RIGHT RETROPERITONEAL APPROACH AT THE L5-S 1 DISK SPACE. ONCE HE HAD IT EXPOSED THEN THE X-RAY WAS TAKEN AND IDENTIFIED THE L5-S1 DISK. HE THEN ENTERED THE DISK WITH A KNIFE AND CURETTED OUT THE DISK MATERIAL. HE THEN SEQUENTIALLY DISTRACTED THE DISK SPACE AND MAXIMUM DISTRACTION WAS AT 12 MM. WHILE THE DISTRACTION WAS DONE, THE DISK WAS CURETTED OUT. ONCE ALL OF THE DISK MATERIAL WAS REMOVED, A TRIAL SPACER WAS INSERTED. X-RAY WAS ( TAKEN AND BASED ON THIS X-RAY WITH THE TRIAL SPACER IN, THE DECISION WAS MADE TO USE THE SMALL FOOTPRINT, 12 MM X 30 MM X 12 DEGREES LORDOTIC PEEK (POL YETHER-ETHER-KETONE) SPACER PACKED WITH BMP (BONE MORPHOGENIC PROTEIN) AND THEN INSERTED INTO THE L5-S1 DISK SPACE. X-RAY CONFIRMED GOOD FINAL POSITION OF THE PEEK SPACER. THEN A 21 MM PLATE WAS ATTACHED TO THE VERTEBRAL BODIES OF L5-S 1 IN GOOD POSITION. ONCE EVERYTHING WAS TIGHTENED DOWN, AND THE COVER PLATE WAS INSERTED, THEN CLOSED THE WOUND . IMPRESSION : "PATIENT HAD LOW BACK PAIN ASSOCIATED WITH DEGENERATIVE DISK DISEASE AT THE LS-S 1 LEVEL, SUPER IMPOSED UPON PREVIOUS SURGERY FROM AN ANTERIOR APPROACH AT THE L3-L4LEVEL AND L4-L5 LEVEL. HE THOUGHT THAT SHE WOULD BE ABLE TO TOLERATE A LEFT PREPERITONEAL OR RETROPERITONEAL APPROACH." NO COMPLICATION NOTICED. (B)(6) 2008 , PATIENT UNDERWENT XRAY EXAMINATION OF LUMBAR SPINE . IMPRESSION : NEW LEVEL OF ANTERIOR FUSION AT THE LS-S1 LEVEL. (B)(6) 2008 ,PATIENT WAS DISCHARGED . (B)(6) 2008 , PATIENT PRESENTED WITH PAIN . HER X RAYS CONFIRMED THE HEALING OF L3-4 <(>&<)> L5-S1 . (B)(6) 2008 , PATIENT PRESENTED WITH LOT OF PAIN IN HER TAILBONE , BACK PAIN , NUMBNESS DOWN HER LEG , CANNOT WALK. (B)(6) 2008 , PATIENT PRESENTED FOR FOLLOW-UP . INJECTION IN HER TAILBONE HAS HELPED HER. (B)(6) 2008 , PATIENT PRESENTED FOR INJECTION . (B)(6) 2009 , PATIENT COMPLAINED OF PAIN DOWN HER LOWER SACRAL AREA. X RAY CONFIRMED THE HEALED ANTERIOR FUSION AT L3-4 , 4-5 AND 5-1. (B)(6) 2009 , PATIENT WAS INFORMED OF HER MRI SCAN . IMPRESSION : THE MRI DOES SHOW SOME FIBROSIS AND CLUMPING OF THE NERVE ROOTS, SO THINK SHE DOCTOR IS DEALING WITH FIBROSIS AND PAIN FROM SCAR TISSUE. (B)(6) 2009 , THE PATIENT PRESENTED WITH BACK PAIN. SHE UNDERWENT FOLLOWING SURGICAL PROCEDURE : LEFT-SIDED L5 TRANSFORAMINAL EPIDURAL STEROID INJECTION WITH FLUOROSCOPY . A 25- GAUGE SPINAL NEEDLE WAS PLACED UNDER FLUOROSCOPIC GUIDANCE AT THE LEFT L5-S 1 FORAMEN . (B)(6) 2009 , THE PATIENT PRESENTED FOR PLACEMENT OF SPINAL CORD SIMULATOR LEAD FOR TRIAL SCREENING. (B)(6) 2009 , THE PATIENT VISITED FOR REMOVAL OF SPINAL CORD STIMULATOR WITH TRIAL LEAD. THE PATIENT WAS STABLE AND LIKELY TO GO WITH PERMANENT IMPLANT. HER SUTURE WERE CUT AND LEADS WERE REMOVED WITH TIPS INTACT. (B)(6) 2009 , THE PATIENT PRESENTED FOR DIAGNOSIS OF ARACHNOIDITIS .THE PATIENT IMPLANTED WITH SPINAL CORD STIMULATOR LEAD AND GENERATOR. A TUNNELING DEVICE WAS USED TO TUNNEL FROM THE LUMBAR INCISION OVER TO THE SUBCUTANEOUS POCKET. THE TAIL OF THE LEAD WAS THEN PLACED THROUGH THE TUNNELING DEVICE. THE TUNNELING DEVICE WAS REMOVED LEAVING THE LEAD TUNNEL FROM THE LUMBAR INCISION OVER TO THE SUBCUTANEOUS POCKET. GENERATOR WAS THEN SECURED TO THE LEAD WITH ALLEN SCREW. IMPEDANCE CHECK SHOWED ALL ELECTRODES FUNCTIONING. BOTH WOUNDS WERE COPIOUSLY IRRIGATED WITH ANTIBIOTIC SOLUTION AND CLOSED WITH INTENUPTED 2-0 VICTYL. NO POST OP COMPLICATIONS. PATIENT WAS DISCHARGED NEXT DAY. (B)(6) 2009, PATIENT PRESENTED FOR X RAY EXAMINATION . IMPRESSION : HEALED ANTERIOR FUSION AT L4-5, L5-S1 WITH POSSIBLE PSEUDARTHROSIS L3-4. (B)(6) 2009, PATIENT VISITED WITH INCREASING BACK PAIN . IMPRESSION ( X RAY ) : GOOD ANTERIOR FUSION NOW L3-4, 4-5 AND 5-1 WITH L5 BEING TRANSITIONAL . (B)(6) 2009 : CT IMAGES OF PELVIS OBTAINED. IMPRESSION : SCLEROSIS OF ILIAC WING NEAR RIGHT SACROILIAC JOINT PROBABLY RELATED TO ARTHRITIS. A SITE OF BONE HARVESTING IS NOTED ALONG THE RIGHT ISCHIUM. (B)(6) 2009 , PATIENT PRESENTED FOR FOLLOW-UP. SI JOINT LOOKS NORMAL. (B)(6) 2009 , PATIENT PRESENTED WITH PAIN SHE HAS PAIN IS IN THE MID TO LOWER LUMBAR SPINE. (B)(6) 2009 , THE PATIENT PRESENTED WITH FOLLOWING PREHOSPITALIZATION DIAGNOSIS : LUMBAR RADICULOPATHY. MULTIPLE SCLEROSIS. . SHE UNDERWENT LUMBAR EPIDURAL STEROID INJECTION WITH FLUOROSCOPY. (B)(6) 2009 , THE PATIENT PRESENTED WITH FOLLOWING PREHOSPITALIZATION DIAGNOSIS : LUMBAR RADICULOPATHY. MULTIPLE SCLEROSIS. THE PATIENT ADMITTED FOR PLANNED DUPENS EPIDURAL CATHETER IMPLANT . POST OP , PARENTERAL OPIOIDS WERE PROVIDED FOR HER PAIN . HER TRIAL WAS DEEMED SUCCESSFUL AND CATHETER WAS REMOVED . (B)(6) 2009 , THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSIS FOR ARACHNOIDITIS . SHE WAS ADMITTED FOR PLANNED IMPLANT OF INTRATHECAL CATHETER AND PROGRAMMABLE PUMP . POST OP , PATIENT COMPLAINED OF A HEADACHE WHICH PERSISTED FOR ANOTHER DAY AS WELL. (B)(6) 2009 , THE PATIENT UNDERWENT CT . ASSESSMENT : THICKENING OF THE ETHMOIDS . HEADACHE IMPROVED BUT COMPLAINT FOR CONSTIPATION. (B)(6) 2009 SHE WAS GIVEN A REPEAT BLOOD PATCH AND NEUROLOGY WAS CONSULTED. (B)(6) 2009, HER PAIN HAD IMPROVED AND HER BOWELS WERE WORKING. PATIENT WAS DISCHARGED. (B)(6) 2010 , PATIENT PRESENTED FOR EXPLANT OF THE ROD PUT IN POST TIBIAL FRACTURE. (B)(6) 2010 , PATIENT WAS INJECTED IN HER KNEE TO REDUCE HER PAIN. SHE UNDERWENT MRI WHICH SHOWED SOME ARTHRITIS ASSOCIATED WITH A BONE INFARCT. (B)(6) 2011 , PATIENT UNDERWENT X RAY . SHE COMPLAINED THAT POST INJECTION OF HER KNEE, IT HURTS MORE. (B)(6) 2011 , PATIENT PRESENTED FOR FOLLOW UP EVALUATION. (B)(6) 2011 , (B)(6) 2011, PATIENT PRESENTED FOR PATIENT PRESENTED FOR LUMBAR EPIDURAL STEROID INJECTION (B)(6) <(>&<)> (B)(6) 2011, PATIENT PRESENTED FOR LUMBAR EPIDURAL STEROID INJECTION WITH FLUOROSCOPY. (B)(6) 2011 , PATIENT PRESENTED FOR LUMBAR EPIDURAL STEROID INJECTION WITH DORSAL ROOT GANGLION RADIOFREQUENCY ABLATION WITH FLUOROSCOPY. (B)(6) 2011 , (B)(6) 2011, (B)(6) 2011- PATIENT PRESENTED FOR FOLLOW-UP MEETING TO SEE HOW HER LEG IS HEALING. (B)(6) 2011 , PATIENT PRESENTED FOR EVALUATION ON LUMBAR EPIDURAL STEROID INJECTION (B)(6) 2011 PATIENT WAS INJECTED WITH MARCAINE AND PREDNISONE IN HER KNEE. (B)(6) 2011 , (B)(6) 2011 , (B)(6) 2012 , (B)(6) 2012 PATIENT PRESENTED FOR FOLLOW-UP EVALUATION (B)(6) 2012, (B)(6) 2012 , (B)(6) 2013 , (B)(6) 2014- PATIENT WAS INJECTED WITH SYNVISC DOSE. PER MEDICAL RECORDS , PROGRAMMABLE PUMP WAS REFILLED ON : (B)(6). PATIENT PRESENTED WITH POST LAMINECTOMY SYNDROME-LUMBAR . UNDERWENT LUMBAR ESI. (B)(6) 2012 , PATIENT COMPLAINED OF PERSISTENT LOW BACK PAIN AT SACRUM DESPITE ESI (EPIDURAL STEROID INJECTION) (B)(6) 2012 , PATIENT PRESENTED WITH LUMBAR PAIN IN HX BACK SURGERY . IMPRESSION : POSTSURGICAL CHANGES,AS ABOVE, SIMILAR TO PREVIOUS STUDY. BROAD BASED ANNULAR BULGE AT L3-4 WITH FORAMINAL ENCROACHMENT, SIMILAR TO SLIGHTLY INCREASED FROM PREVIOUS STUDY. SMALL CENTRAL DISC PROTRUSION AT L4-5 WITH FORAMINAL ENCROACHMENT. PLEASE NOTE THE RIGHT FORAMINAL ENCROACHMENT LATERAL SCAR IS LESS PROMINENT THAN ON PRIOR STUDY. INCIDENTAL FINDING OF CYST IN THE INFERIOR POLE OF THE LEFT KIDNEY. (B)(6), PATIENT PRESENTED WITH INCREASE IN PAIN IN L3 DERMATOME. SHE UNDERWENT RIGHT L3-L4 TRANSFORAMINAL EPIDURAL STEROID INJECTION . (B)(6), PATIENT PRESENTED FOR IMPLANTED PROGRAMMABLE PUMP REFILL . PATIENT CONDITION HAS IMPROVED. (B)(6) 2012, PATIENT UNDERWENT MRI PROCEDURE OF LUMBAR SPINE WITH <(>&<)> WITHOUT CONTRAST. IMPRESSION : POSTOPERATIVE CHANGES WITH STABILIZATION OF THE LOWER LUMBAR VERTEBRAL SEGMENTS, SIMILAR TO PREVIOUS STUDY. FINDINGS OF ANNULAR BULGE AND LATERAL FORAMINAL ENCROACHMENT SIMILAR TO PREVIOUS STUDIES. FINDINGS TO SUGGEST A RECURRENT DISC IS NOT ESTABLISHED. (B)(6) 2012 , PATIENT PRESENTED WITH LOW BACK PAIN. (B)(6) 2012 , (B)(6) 2013 , PATIENT PRESENTED FOR IMPLANTED PROGRAMMABLE PUMP REFILL AND REPROGRAM. (B)(6) 2013 , PAIN IS WELL CONTROLLED. PATIENT VISITED FOR FOLLOW-UP AND PUMP REFILL. 10 MAY 2013 , PATIENT PRESENTED FOR FOLLOW-UP . PAIN HAS IMPROVED. (B)(6) 2013 , PATIENT PRESENTED WITH CERVICAL SPONDYL W MYLOPATHY ALSO UNDERWENT MRI OF SPINE. 10 JUN 2013 , PATIENT PRESENTED FOR MRI C SPINE W/O CONTRAST . IMPRESSION : DEGENERATED DISCS SEEN AT ALL LEVELS OF THE CERVICAL SPINE. THERE IS STRAIGHTENING OF NORMAL CERVICAL LORDOSIS. AT C3-4 THERE IS A BROAD BASED DIFFUSE DISC THAT EFFACES THE CORD AND NARROWS THE LEFT NEURAL FORAMINA. OVERALL, THERE IS NEURAL CANAL NARROWING AT THIS LEVEL. AT G4-5, NEURAL FORAMINAL NARROWING IS PRESENT. DIFFUSE DISC BULGE IS SEEN WITH MOREFOCAL DISC PROTRUSION AT THE ORIGIN OF THE LEFT NEURAL FORAMINA. THERE IS MILD EFFACEMENT OF THE CORD. MARROW SIGNAL IS NORMAL. CORD IS OF NORMAL SIZE AND SIGNAL. (B)(6) 2013 , PATIENT VISITED THE FACILITY AND REQUESTED CHANGE IN PRESCRIPTION OF DRUGS. (B)(6) 2013 , PATIENT PRESENTED WITH BRACHIAL NEURITIS . FOLLOWING PROCEDURE WAS PERFORMED: CERVICAL EPIDURAL STEROID INJECTION WITH FLUOROSCOPY . (B)(6) 2013 , PATIENT PRESENTED WITH CERVICAL SPONDYL MYLOPATHY, BRACHIAL NEURITIS , POST LAMINECTOMY SYNDROME LUMBAR. PATIENT MADE VISIT TO FACILITY ON : (B)(6) 2013, PATIENT MADE ANOTHER VISIT AND DIAGNOSED WITH POST LAMINECTOMY SYNDROME - LUMBAR (B)(6) 2013 , PATIENT MADE ANOTHER VISIT AND DIAGNOSED WITH CERVICAL SPONDYL W MYLOPATHY, POST LAMINECT SYND LUMBAR. HER PAIN HAS IMPROVED. FLUOROSCOPY PROCEDURE WAS PERFORMED. (B)(6) 2013 PATIENT VISITED FOR PRESCRIPTION. HER PAIN HAS IMPROVED. FLUOROSCOPY PROCEDURE WAS PERFORMED. (B)(6) 2013 , PATIENT VISITED WITH NECK PAIN, ACHING ,THROBBING, CRAMPING. PATIENT VISITED FOR THE FOLLOW-UP EVALUATION. (B)(6) 2013 , PATIENT VISITED THE FACILITY . (B)(6) 2013 , PATIENT PRESENTED WITH POST-LAMINECTOMY SYNDROME-LUMBAR . PAIN HAS IMPROVED . THE PATIENT UNDERWENT LUMBAR EPIDURAL STEROID INJECTION WITH FLUOROSCOPY . (B)(6) 2013 , PATIENT PRESENTED FOR FOLLOW-UP AND COMPLAINED OF LOW BACK PAIN . (B)(6) 2012 , (B)(6) 2013 , PATIENT PRESENTED WITH PAIN WHICH HAS INCREASED WITHOUT PO OPIOID. THE PUMP WAS REPROGRAMMED TO SHOW THE CHANGE IN RESERVOIR VOLUME AND THE INFUSION WAS PROGRAMMED FOR INTRATHECAL DILAUDID 12MG (B)(6) 2013, PATIENT PRESENTED WITH CERVICAL SPONDYL W MYLOPATHY, BRACHIAL NEURITIS , POST LAMINECT SYND LUMBAR. FOLLOWING PROCEDURE WAS PERFORMED : REPROGRAM IMPLANTED PROGRAMMABLE PUMP. THE PATIENT WAS IDENTIFIED. THE PUMP WAS INTERROGATED THEN REPROGRAMMED TO INFUSE AT WAS INTRATHECAL MORPHINE (B)(6) 2013 , (B)(6) 2013 , (B)(6) 2013 - PATIENT PRESENTED FOR ANOTHER PROCEDURE AS PAIN HAS INCREASED WITHOUT PO OPIOID AND INCREASE BASAL RATE AND PTM, IF THUS DOESN'T HELP I'D RECOMMEND INCREASING BUPIV .PER NOTES THE PUMP WAS REPROGRAMMED TO SHOW THE CHANGE IN RESERVOIR VOLUME AND THE INFUSION WAS PROGRAMMED (B)(6) 2013 , PATIENT DIAGNOSED FOR LUMBAR POST LAMINECTOMY SYNDROME. HER PAIN OVER THE LUMBAR FACETS WITH STRESS MANEUVERS. (B)(6) 2014 PATIENT PRESENTED WITH LUMBAR POST LAMINECTOMY SYNDROME. HER PAIN HAS INCREASED. SHE UNDERWENT FLUOROSCOPY PROCEDURE -LUMBAR EPIDURAL STEROID INJECTION (B)(6) 2014 , PATIENT PRESENTED FOR LUMBAR POST LAMINECTOMY SYNDROME . (B)(6) 2014 , PATIENT PRESENTED WITH CERVICAL SPONDYL W MYLOPATHY, BRACHIAL NEURITIS , POST LAMINECTOMY SYND LUMBAR. FOLLOWING PROCEDURE WAS PERFORMED : PROGRAMMABLE PUMP REFILL. (B)(6) 2014 , (B)(6) 2014 -PATIENT PRESENTED WITH CERVICAL SPONDYLE WITH MYLOPATHY, BRACHIAL NEURITIS , POST LAMINECTOMY SYNDROME LUMBAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 561205 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M110607AAD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |