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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number 7510200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Weakness (1967); Pain (1994); Swollen Glands (2092); Tingling (2171); Chills (2191); Hernia (2240); Stenosis (2263); Ulcer (2274); Discomfort (2330); Numbness (2415); Post Operative Wound Infection (2446); Sleep Dysfunction (2517); Weight Changes (2607)
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2007 the patient presented with lower back pain and hypertension.The patient underwent chest x-rays which showed no evidence of active cardiac/pulmonary disease.The patient also underwent a lumbar spine mri which demonstrated mild posterior right para-medium disc protrusion, l5-s1.On (b)(6) 2007 the patient presented with severe constant lower back and right leg pain.Medications: vicodin and methacarbamol.On (b)(6) 2007 the patient presented with a 16 year history of lower back pain with worsening right leg pain and the preoperative diagnosis of degenerative disc disease l5-s1 and lumbar disc herniation l5-s1.The patient underwent surgery which consisted of a l5-s1 laminectomy; posterior lumbar interbody fusion using bmp containing sponges and leopard cages; and a posterolateral arthrodesis, pedicle screw stabilization l4-s1 using (expanding) pedicle screws.Per the operative report ¿¿the end plates were decorticated and then the leopard cage was packed with bmp containing sponges and local autograft and then placed in the interspace.There appeared to be a tight fit.The titanium rods were then removed and replaced and compression was carried out across the pedicle screws to firmly seat the interbody cage.An epidural catheter was then placed and a crosslink connector was placed as well.The wound was then irrigated with 3 liters of bacitracin containing solution.An x-ray was obtained which revealed proper placement of the pedicle screws and the cage.The medium hemovac drain was placed and then this wound was then irrigated and then transverse processes were decorticated and the bmp containing sponges and local autograft were placed in the posterolateral gutters.¿ no patient complications were noted.Pathology on the l5-s1 disc showed fragments of cartilage with changes.On (b)(6) 2007, the patient was discharged from hospital.On (b)(6) 2007 the patient presented with severe post-operative wound drainage and infection.The patient was admitted to hospital where they underwent surgery which consisted of incision down to the subfascial plane and drainage of the wound.A wound culture revealed e.Coli.On (b)(6) 2007 the patient presented constant wound drainage and low grade fever.On (b)(6) 2007, while in hospital the patient presented with venous insufficiency, cellulitis in the right foot, and the need for long term intravenous access for antibiotic therapy.The patient underwent surgery for the placement of a picc line.No patient complications were noted.On (b)(6) 2007 the patient was discharged from hospital.On (b)(6) 2007, in a telephone encounter, it was reported that the patient was having episodes of hot and cold; was hardly eating; and was very weak.The patient presented in an er visit with back pain and chills.The patient underwent labs which were abnormal.On (b)(6) 2007 the patient presented constant back pain.On (b)(6) 2007 the patient underwent labs which revealed low hemoglobin, hematocrit, neut%, urea nitrogen, creatinine, potassium, b un/creat ratio and high platelets, and eosinophil.On (b)(6) 2007 the patient presented continuing back pain, diarrhea, and nausea.Per the encounter notes, the patient was admitted to hospital for evaluation.On (b)(6) 2007 the patient presented with a wound infection involving the lumbosacral region with drainage, hypertension, and intractable pain.The patient was reported to have been vomiting for two days.The patient was admitted to hospital and cultures revealed pseudomonas.The patient was placed on zosyn and after improvement, switched to cipro.While in the hospital, the patient presented with blood in urine.On (b)(6)2007, the patient underwent labs which revealed low potassium and creatinine and high glucose.On (b)(6) 2007 the patient presented with infection and diarrhea.The patient underwent imaging for a picc check.The patient also underwent a lumbar spine mri which demonstrated enhancing scar and granulation tissue filling the right lateral recess at l5-s1 and fusion hardware at l5 and s1.There was postoperative fluid collection with the largest at the level of the superior s1 pedicles and extended contiguously into the deep fascia plane of the lower back, extending superiorly and appeared to drain to the skin at the level of l3-4 disk space.It extended contiguously to the left of the thecal sac at l5-s1 but did not compress the thecal sac or result in stenosis.On (b)(6) 2007 the patient underwent the placement of a picc line for longterm antibiotic treatment.No patient complications were noted.On (b)(6) 2007 the patient was discharged from hospital.The patient was sent home on percocet, valium, prilosec, and cipro.On (b)(6) 2007 the patient presented with non-healing/slow healing wound to the lumbar area.On (b)(6) 2007 a wound vac was initiated to the lumbar sacral region.On (b)(6) 2007 the patient presented for a wound examination ¿ which was improving ¿satisfactory¿.On (b)(6) 2007 the patient reported lessening back pain and did not need narcotic pain medication anymore.On (b)(6) 2007 the patient underwent labs which revealed low hemoglobin, hematocrit, urea nitrogen, potassium, chloride, bun/creat.Ratio, osmolality and high white cell count, platelets, and glucose.On (b)(6) 2007 the patient reported no pain in their back and they were not taking narcotic pain medication only occasional tylenol.On (b)(6) 2007 the patient presented with a sacral wound that was decreasing in size.On (b)(6) 2007 the patient was admitted to hospital with recurrent vomiting, fever, severe hypokalemic, diarrhea, abdominal cramps, and wound infection.Labs revealed low potassium and elevated liver function.The patient underwent an abdomen obstructive series with pa chest which revealed no acute pulmonary disease and no obstruction.The patient was started on potassium supplements as well as a potassium bolus.On (b)(6) 2007 the patient presented with vomiting, abdominal pain, nausea and elevated liver function studies.The patient underwent an abdominal ultrasound which showed no evidence of gross intrahepatic or extra-hepatic duct dilation.The bile duct was prominent at 7.6mm.The patient underwent labs which were positive for c.Diff toxin.On (b)(6) 2007 the patient underwent labs which revealed high glucose, chloride, alk pho, ast, alt, rdw and low creatinine, prot total, albumin, a/g rate, rbc, hgb, hct, mcv,and mchc.The patient was discharged from hospital.The patient was sent home on reglan, compazine, aciphex, and cipro.On (b)(6) 2007 the patient presented with improving appetite and an improving wound site.On (b)(6) 2007 the patient presented with continuing back discomfort and abdominal pain and underwent a ct of the abdomen and pelvis which demonstrated relative bowel wall thickening involving the sigmoid colon with mild induration of the perirectal fascia which may have been secondary to remote diverticular disease or may have been related to possible radiation therapy changes.There was mild prominence of the common bile duct in the pancreatic head.The patient also presented with a headache and underwent a brain ct which showed no areas of abnormal increased or decreased density, no intra or extra-cerebral bleed, midline shift, or mass effect.The patient was scheduled for an evaluation for difficulty speaking.On (b)(6) 2007 the patient presented with continuing pain in the back, per the encounter notes, the patient had seen another doctor for an evaluation of their throat for difficulty speaking and they were now undergoing speech therapy.X-rays revealed adequate progression of the fusion.On (b)(6) 2007 the patient presented with pain and underwent lumbar spine x-rays which showed post-surgical changes.There was atherosclerosis, some mild spurring at several levels suggesting degenerative disc disease, mild irregularity of the anterior-superior endplate of l4, and the right screw extended more laterally than the left s1 screw.On (b)(6) 2007 the patent underwent labs which reported low hematocrit, creatinine, albumin and hgb and a high mpv and sgot.The patient presented with a raw bleeding wound at the lumbar site, on (b)(6) 2007 the patient was admitted to hospital with intra-abdominal pain and diarrhea with tenderness in left and rightlower quadrant of the abdomen.Abdominal x-rays with pa chest were taken which showed no acute disease of the chest and non-obstructive bowel gas pattern.A ct scan revealed evidence of colitis, suggestion of a mild ileus, colonic wall thickening, and adrenal nodules.The patient was diagnosed with c.Diff.Colitis.Final diagnosis: colitis associated with leukocytosis and hypokalemia.The patient also presented with neck pain and underwent cervical spine x-rays which were unremarkable.On (b)(6) 2007 the patient was discharged from hospital.On (b)(6) 2014 the patient presented with improving lumbar and sacral wound sites.On (b)(6) 2007 the patient presented with intermittent back discomfort.The patient reported going to the hospital several weeks prior for low potassium and a c.Diff colitis infection.Per the encounter notes the neurologic exam was without change.Lumbar spine x-rays were taken which showed status post laminectomy and fusion at l5-s1 with an expected post-operative appearance and instrumentation intact.Solid bony fusion was not yet evident.On (b)(6) 2007 the patient presented constant back pain and lower extremity weakness with numbness and tingling in the shin.Per the encounter notes, it reported that the patient had been allergic to the staples used in a previous surgery and they had had to be ¿cut back open to get that out but her infections are cleared up now¿.The patient reported trouble speaking since the surgery secondary to vomiting and vocal cord being swollen; loss of weight (100lbs); and difficulty sleeping.The patient also stated they the ultram medication was not working well.The patient was on disability.On (b)(6) 2007 the patient presented with generalized weakness and diarrhea (onset 4 days prior).On (b)(6) 2007 the patient presented with improving pain.Per the encounter notes, x-rays revealed adequate progression of the fusion.Radiographic impression: grossly stable changes from lumbar fusion l5-s1.Mild degenerative changes persisted.On (b)(6) 2008 the patient presented with occasional back pain.X-rays revealed adequate progression of the fusion.In an (b)(6) 2008 letter, the doctor states that the patient had been on multiple medications, including antibiotics and chemotherapy over the past three years and that it was possible the medications interfered with the health of the patients teeth.On (b)(6) 2008 the patient underwent lumbar spine x-rays which showed anterior and posterior lumbar spinal fusion l5-s1 and mild d extrocurvature of the mid lumbar spine (possible due to positioning).There were also atherosclerotic vascular calcifications noted in the abdominal aorta.On (b)(6) 2011 the patient presented with severe, piercing, sharp back pain that radiated down the the back of the left leg.The patient reported it tingled a lot.The patient reported that the pain woke them up at night and was worse with movement.Medications: oxycodone, vitamin e, synthoid, topamax, and, methocarbamol.The patient also reported starting hyperbolic treatments for thyroid cancer two weeks prior.A review of x-rays of the lumbar spine revealed adequate progression of the fusion without evidence of hardware failure or nonunion.On (b)(6) 2011 the patient presented with pain.The patient reported that their symptoms had worsened since undergoing hyperbaric treatments 3 weeks prior, secondary to a reaction from radiation.On (b)(6) 2011 the patient presented with lower back discomfort.On (b)(6) 2011 the patient underwent labs which revealed a high white count.On (b)(6) 2011 the patient presented with low back pain and bilateral leg pain, numbness and variable weakness.The patient underwent a lumbar spine mri w and w/out contrast, which demonstrated straightening of the usual lumbar lordosis and mild upper lumbar levoscoliosis; epidural fibrosis; severe l4-l5 central spinal canal stenosis; minimal left l3-4 and mild moderate bilateral l4-l5 foraminal stenosis; nonspecific serpentine hypointense signal within the lateral sacral ala.Sacral insufficiency fracture not excluded; benign bilateral adrenal adhesions; and diffusely heterogeneous marrow spinal signal possibly reflecting osteoporosis.On (b)(6) 2011 the patient presented with lower back and bilateral buttocks pain.A mri was reviewed with the patient which showed severe stenosis at the l4-l5 level.It was stated in the encounter notes that the patient was not a good candidate for surgery as she was undergoing hyperbaric treatments.On (b)(6) 2011 the patient reported worsening lower back pain with numbness and tingling in her leg when standing or walking and which limited activities.The patient reported having more seizures and had been started levetiracetam.In the event notes it stated the patient ¿was not undergoing the hyperbaric treatments because of her seizure disorder.¿ surgery was discussed and tentatively planned.On (b)(6) 2012 in a note concerning an upcoming spinal surgery, the doctor noted that anticonvulsants would need to be continued via iv during recovery.On (b)(6) 2012 the patient present for a pre-op ekg which was normal.On (b)(6) 2012 the patient underwent labs which revealed high sodium, globulin and a low a/g ratio.On (b)(6) 2012 the patient complained of worsening pain in back and numbness, pain and tingling in legs.The patient presented with the diagnosis of lumbar spinal stenosis at l4-l5 and l5-s1 and underwent surgery which consisted of a hardware revision at l5-s1; decompression laminectomy; discectomy; posterior lumbar interbody fusion using with interbody cage; bmp containing sponges ; local auto graft ; pedicle screw stabilization to l4 to l5 to s1 and pedicle screws placed at l4.Per the operative report an ¿¿interbody cage of size 10 mm were then packed with bmp containing sponges and local autograft was then placed into the disk space.There appeared to be a tight fit.The midas rex was then used to fashion and incise the pedicles at l4 bilaterally.Each pedicle was cannulated and tapped and pedicle screws were placed.Each pedicle screw was tested using evoked emgs.There was no evidence of pedicle screw breakout or nerve irritation.Pedicle screws were then connected with pedicle screws at l5-s1 using titanium rods.X-ray was then obtained, which revealed proper placement of the pedicle screws and the interbody cage at l4-l5.Wound was irrigated with 3 l of bacitracin containing solution.The midas rex was used to decorticate the transverse process of l4-l5.The crosslink connector was placed.Bmp containing sponge and local autografts were placed on posterolateral gutter¿¿ it should be noted that dense scar tissue was encountered in the procedure.No patient complications were reported.On day three post op the patient reported headache.On (b)(6) 2012 the patient presented with headache and increased drainage from the hemovac.The patient underwent surgery which consisted of a wound exploration for a possible spinal fluid leak.No csf was identified at the time of the surgery however dura was covered with duraseal and csf leak progressions were continued.No patient complications were noted.The patient remained at bed rest until (b)(6) 2012.On (b)(6) 2012 the patient was discharged from hospital.On (b)(6) 2012 the patient presented with some wound drainage.The patient was to continue on levaquin and percocet.On (b)(6) 2012 the patient presented with some wound drainage and granulation tissue in the mid portion of the wound.The patient was to continue on levaquin.On (b)(6) 2012 the patient presented with continued wound drainage and granulation tissue.On (b)(60 2012 the patient presented with some wound drainage and a fair amount of granulation tissue in the mid portion of the wound.The patient was given a prescription for percocet and levaquin.The patient underwent labs revealing high sedimentation rates, rdw, and platelets and low rbc, hemoglobin, and hematocrit.On (b)(6) 2012 the patient presented with improved wound drainage with slight granulation tissue.Per the encounter notes x-rays revealed adequate progression of the fusion.The patient was to continue on levaquin.On (b)(6) 2012 the patient presented with spinal stenosis and underwent lumbar spine x-rays which demonstrated more instrumentation since an (b)(6) 2008 xray and mild spondylolisthesis at l4-5.On (b)(6) 2012 the patient presented with pain in lower back into the left hip and somewhat down the leg.The patient reported the pain had worsened over the last month.Per the encounter notes x-rays revealed adequate progression of fusion without evidence of hardware failure.Medications: synthroid, oxycodone-acetaminophen, methocarbamol, and topamax.On (b)(6) 2012 the patient presented with back pain and underwent lumbar spine x-rays which demonstrated no solid bony fusion, endplates about the operated l4-5 disc space were indistinct with areas of lucency suggesting infection and some radiolucency about the screws at l5-s1.On (b)(6) 2012 the patient presented with lumbar pain and left radiculopathy.It also recounted that the patient had undergone four surgeries.The patient underwent a lumbar spine mri which demonstrated fusion of l4, 5 and s1; a l4-5 small bulge of the graft; osteophyte from the hypertrophied facet causing moderate left foraminal narrowing; l5-s1 disc projecting broadly posteriorly with an annular tear and mild neuroforaminal narrowing l5-s1.In the posterior elements of l5, septated fluid collection measuring 2.5x3.1x2.2 cm was present without appreciable mass.Edema was seen in the subcutaneous tissues ¿ all consistent with recent surgery.On (b)(6) 2012 the patient underwent labs which reported low hemoglobin, hematocrit, mcv, and mch and high sedimentation rate, rdw and platelets.On (b)(6) 2012 the patient presented with left buttock, left groin, left thigh pain.The patient reported that this comes on with standing or walking longer than 20 minutes.The patient also reported left groin and left thigh pain at the end of the day as well as pain with rom of left leg and thigh.Review of a mri revealed post op changes at l4, l5, and s1.¿osteophyte from hypertrophied facet cases moderate left neuroforaminal narrowing¿in the posterior elements of l5, separated fluid collection measuring 2.5x3.1x2cm is present without appreciable mass effect.Edema is seen in the subcutaneous tissues all consistent with recent surgery.¿ on (b)(6) 2012 the patient presented with lower back, left buttock, left groin, and left thigh pain.The patient complained the symptoms were worsening.Per the encounter notes x-rays revealed adequate healing without evidence of hardware failure or loosening.The patient underwent labs which revealed a high sedimentation rate and rdw and low hemoglobin and mch.On (b)(6) 2012 the patient presented post laminectomy for lumbar spine radiographs which showed increased obstruction of endplates along the l4-l5 disc space suspicious infection/discitis and ongoing lucency along the right pedicle screws of l5 and s1.On (b)(6) 2012 the patient presented with back pain and underwent lumbar spine x-rays which were suspicious for discitis/vertebral body osteomyelitis at l4-l5.On (b)(6) 2012 the patient presented with pain in lower back and into the left leg.X-rays revealed ¿aggressive healing at the l4-l5 level.¿ in a (b)(6) 2012 letter, the doctor recommended the patient seek pain management services for her chronic pain medication.
 
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.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on: (b)(6) 2007: patient presented for an office visit and diagnosed with hnp and lumbar fusion.(b)(6) 2007: the patient presented for consultation with main problem of lumbar disk herniation at l5-s1 as well as ddd.The patient complains of generalized weakness.The patient does have severe pain in her low back area and also sciatica down both legs, especially the left leg.Physical examination: neurological the patient does have a straight leg raising test to 45 degrees on the left and 60 degrees on the light.The patient has severe tenderness and pain in the lumbosacral region.There is no sensory level.Reflexes are diminished in both lower extremities.Plantars are both downgoing.There are no cerebellar signs, no involuntary movements.Clinical impression:1) herniated nucleus pulposus at l5-s1.2) degenerative disk disease involving the lumbar region.3) history of hypertension.4) chronic low back pain.(b)(6) 2007: the patient was admitted to the facility.The patient presented with following pre-operative diagnosis: 1) degenerative disk disease ls-s1 2) lumbar disk herniation l5-s1.3) herniated nucleus pulposa (hnp).The patient underwent following procedures: ls-s1 laminectomy, discectomy , posterior lumbar interbody fusion using rh-bmp2/acs containing sponges and leopard cages, posterolateral arthrodesis, pedicle screw stabilizationl4 to s1 using [expanding] pedicle screws.Assessment: patient complaints of chronic lower back pain, some right handed radicular symptoms.Indications for procedure: 16year history of lower back pain, worsening pain down to the right leg to her calf.She has had long trial of conservative treatment without significant improvement in her pain.Mri revealed degenerative disk disease at the l5-s1 level with disk herniation to the right side.Per the op notes, the ls-s1 disk herniation was identified.The disk was incised and the disk material was removed using curettes and pituitary rongeurs.The end plates were decorticated and then the leopard cage was packed with rh-bmp2/acs containing sponges and local autograft and then placed in the interspace.There appeared to be a tight fit.An x-ray was obtained which revealed proper placement of the pedicle screws and the cage.The transverse processes were decorticated and the bmp containing sponges and local autograft were placed in the posterolateral gutters.No spontaneous lower extremity emg activity was observed throughout the procedure.Direct electrical stimulation of the spinal cord nerve roots was not performed.Intra-op some x-ray was conducted on lumbar spine.Following implants were used along with rhbmp-2/acs: depuy crosslink ,expedium screws ,baxter floseal ,depuy screws ,syntheis leopard cage and depuy rods.Her activity was gradually increased.She had improvement in her numbness in the right leg, pain in the right leg and back pain.Her wound healed without signs of infection.She had a mild temperature elevation.This resolved with increased activity and ambulation.(b)(6) 2007: the patient underwent x-ray of lumbosacral spine due to backache.Impression: limited single intraoperative lateral view of lumbar spine shows posterior fusion of l5-s1.(b)(6) 2007: the patient underwent chest x-ray due to fever.Impression: mild pulmonary vascular congestion.No evidence of an active pulmonary infiltrate or pleural effusion (b)(6) 2007: the patient presented for consultation.She reports over the last couple of days, she has had drainage from the lower portion of her incision.She also reports she has a low grade fever.She has some induration around her wound margins.She had some chills.The patient had a coagulase-(b)(6) in the blood one of one bottle on (b)(6) 2007 and seemingly the patient had no fever at that time.Therefore, this was deemed to be a contaminant.A urine culture on the same day had 10,000 colonies of e.Coli, which was susceptible to everything.No numbness or tingling in the legs.Physical examination: extremities: she has leg edema.Assessment: surgical site infection with likely component of osteomyelitis in view of high sed rate.It is possible that the e.Coli that the patient had in the urine could have been transiently bacteraemic time.(b)(6) 2007: the patient was admitted to facility.The patient presented with following pre-op diagnosis: wound infection status post l5-s1 laminectomy and fusion.The patient underwent following procedure: incision and drainage of infected postop wound.(b)(6) 2007: the patient underwent following examination: 1) sp insert picc per wo sq pt 5+yrs 2) sp guidance w fl cvad pl-r-rem due to postoperative wound infection.Impressions: fluoroscopically and sonographically guided placement of a double lumen 5-french 38.5 length pic catheter.(b)(6) 2007:the patient underwent following examination: sp fluoro picc/cvc insert/chec due to postoperative lumbar wound infection.Impression: normally functioning picc line, without evidence of obstruction, kinking, dislocation or extravasation.(b)(6)2007: the patient was admitted to home health services on (b)(6) 2007 and discharged on (b)(6) 2007: the patient presented with follow up due to back pain.Physical examination: neck: normal inspection.Neck non tender.Back: abnormal inspection.No back tenderness.Surgical wound free of purulent drainage.No erythema or evidence of infection.Skin is free of cellulitis.Extremities: extremities exhibit normal rom.Extremities non tender.Neuro: oriented x 3.Mood/affect; normal.No motor deficit.No sensory deficit.Reflexes normal.Clinical impression: post op surgical pain.(b)(6) 2007: patient underwent ap/lateral x-ray of lumbar spine due to back pain.(b)(6) 2007: the patient presented for consultation due to post laminectomy wound infection, rule out infected hardware.Lumbar spine area examination is significant for several mattress tension sutures in the back wound.In the central portion of the wound, there is about a 6 cm open area which is about 3.5 deep but which seems to tunnel deeper.There is a moderate amount of serosanguineous drainage from that area.Clinical impression: 1.Status post l5-s1 laminectomy with polymicrobial postoperative wound infection, which now appears to be progressive.There is significant concern about a deep- seated abscess or possibly hardware infection.2.Increased transaminases.On review, it appears she has had these elevated in the past.These may be exacerbated by the medications she is currently on, but will check a hepatitis panel as well.(b)(6) 2007: the patient underwent following examinations: 1) ct recon 3d non indep wk sta 2)ct l-spine w/o contrast 3)xr abdomen oest series w/pa chest due to low back pain and lumbar infection.Conclusion: extensive postsurgical change l5-s1 as described in detail above.Multiple collections of gas within the soft tissues dorsal to the thecal sac at l5-s1, with associated soft tissue thickening in this area.These findings may be postsurgical in etiology although the possibility of an infectious process is not excluded radiographically on the basis of this examination.Loss of definition of the margins of the thecal sac at l5-s1, right greater than left.This may be inflammatory or postsurgical.Cannot exclude the possibility of persistent or recurrent disc protrusion at this level.No significant abnormality identified from l1 through l4-5.(b)(6) 2007: the patient was admitted on (b)(6) 2007.Review of systems: neurological - complains of generalized weakness.No focal motor or sensory symptoms.The patient denies any leg pain, but she has a lot of back pain, mostly in the low back area at the site of the wound.(b)(6) 2007:the patient underwent homecare treatment.The patient has increased healing of lumbar and sacral area wounds.At the beginning of service large amount of drainage was noted from each dressing.Wound vac initiated on (b)(6) 2007.Wound responded and was able to be discontinued to distal sacral area on (b)(6) 2007 and lumbar area on (b)(6) 2007: the patient presented for follow up.She still has some minimal drainage.She is progressing satisfactorily.(b)(6) 2007: the patient was diagnosed with open wound back-comp and decubitus ulcer,low back and was prescribed v.A.S therapy system.(b)(6) 2007: the patient presented for follow up.She continues to have some discomfort in her back.She reports she had some difficulty speaking.She is progressing satisfactorily.(b)(6) 2007: the patient underwent ap/lateral x-rays of lumbar spine due to low back pain.(b)(6) 2007: the patient presented with low back pain, tingling and left leg pain.Pain is rated as 9 out of 10.Pain is present all the time, much worse with movement, bending forward and prolonged standing.The patient has weakness n back and left leg.(b)(6) 2007: the patient underwent ap and lateral x-ray of lumbar spine due to lumbago and pain.Findings: three radiographs of the lumbar spine show posterior fusion procedure at ls-s1 with posterior instrumentation present.There is also a fusion device projecting over the ls-sl disc space level.There is atherosclerosis.There is some mild spurring at several levels suggesting degenerative disc disease.There is mild irregularity of the antero-superior endplate of l4.The right s1 screw extends more laterally than the left sl screw.(b)(6) 2007: sacral area treatment was discontinued.(b)(6) 2007: the patient was admitted to the facility.The patient was diagnosed with 1.Colitis associated with leukocytosis.2.Hypokalemia.3.Status post lumbar laminectomy.(b)(6) 2007: the patient underwent x-ray of cervical spine due to neck pain.Impressions: unremarkable examination.(b)(6) 2007: the patient presented with back pain and lower extremity weakness.The patient has numbness and tingling in th shins,usually in the morning.The patient has a history of hereditary back disorders.She does have difficulty with the medication causing her to vomit and she states that she also has had trouble speaking since the surgery secondary to vomiting and vocal cords being swollen.She does not sleep well.The physical therapy appointment consists of initial evaluation followed by instruction in home exercise program to focus on core strengthening and stability patient tolerated treatment well.(b)(6) 2007:the patient has improved gait and improved health condition wounds fully granulated.The patient demos increased endurance, mobility and activity.(b)(6) 2011: the patient presented with an office visit due to lumbago.Assessment: patient requires skilled rehabilitative therapy in conjunction with a home exercise program to address the problems.
 
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Brand Name
INFUSE BONE GRAFT
Type of Device
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key3980103
MDR Text Key16180210
Report Number1030489-2014-03396
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,consumer
Reporter Occupation Attorney
Type of Report Initial
Report Date 07/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/01/2009
Device Catalogue Number7510200
Device Lot NumberM110604AAI
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/27/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight96
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