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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 7510800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anemia (1706); Dyspnea (1816); Fatigue (1849); Hematoma (1884); Muscle Spasm(s) (1966); Neuropathy (1983); Pleural Effusion (2010); Swelling (2091); Weakness (2145); Chronic Obstructive Pulmonary Disease (COPD) (2237); Stenosis (2263); Depression (2361); Numbness (2415); Neck Pain (2433); Post Operative Wound Infection (2446); Sleep Dysfunction (2517)
Event Type  Injury  
Manufacturer Narrative
On (b)(6) 2010: pt underwent chest x-ray due to shortness of breath.Impression: hazy right lung base opacity may represent small right pleural effusion with layering & associated atelectasis, developing pneumonia cannot be excluded.Linear lt.Lung base opacity is consistent with atelectasis.On (b)(6) 2010: pt underwent chest x-ray due to respiratory distress.Impression: picc line no longer present.No evidence of acute disease in the chest.On (b)(6) 2010: pt underwent chest x-ray due to picc line insertion.Impression: lt.Picc is in satisfactory position.Bibasilar opacities with small bilateral pleural effusions.Differential diagnosis includes atelectasis, aspiration or pneumonia.On (b)(6) 2010: pt was discharged.On (b)(6) 2010: pt underwent right lower leg x-ray due to fall, laceration.Impression: orthopedic device with a staple into the anterior tibial region.Lucency along the cortex that the emergency room felt might be a fracture.I do not believe this is a definite fracture of the tibia at that location.It is only seen in its one projection.Degenerative changes of the knee.On (b)(6) 2010: pt underwent g/colon tube check with contrast.Impression: j tube in good position in the jejunum with no extravasation or obstruction seen.On (b)(6) 2011: pt underwent g/colon tube check with contrast due to history of malnutrition.Impression: lateral placement of the j tube which appears to have been pulled out of the jejunum & resides lateral to the jejunum with contrast extending into the jejunum following injection of the j tube.The catheter should be replaced.On (b)(6) 2011: pt underwent lumbar spine x-ray due to back pain.Impression: post surgical changes.Retrolisthesis of l2 with respect to l3.Pt underwent ct thoracic spine without contrast due to back pain.Impression: multilevel degenerative disk changes.No evidence for acute compression fracture.Pt underwent ct lumbar spine without contrast due to back pain.Impression: retrolisthesis of l2 on l3.No evidence for acute fracture.Multilevel postoperative changes of the posterior elements.On (b)(6) 2011: pt underwent hip x-ray due to pain.Impression: unremarkable lt.Hip.Pt underwent lumbar spine x-ray.Impression: post surgical change.There is scoliosis to the lt.There are degenerative changes.There is spondylolisthesis most pronounced at l2-3, less pronounced at l3-4.On (b)(6) 2011: pt underwent chest x-ray due to pain.Impression: prominent pulmonary hila bilaterally.Pt underwent ct head without contrast due to pain.Impression: mild bilateral proptosis.No ct evidence of acute intracranial process.On (b)(6) 2011: pt was admitted foe following: rule out sepsis.Hypocalcemia.Pt underwent mri lumbar spine without contrast due to numbness & tingling.Impression: incomplete evaluation of the draining wound with in the posterior lumbar subcutaneous tissue.Post contrast sagittal & axial t1 fat sat images to the lumbar spine should be obtained.No evidence of diskitis.Improved bone marrow edema is present with in the l1 vertebra.Increased degenerative endplate changes noted within the l2, l3 & l4 vertebral bodies.Extensive post operative change with stable acute kyphosis centered at l1.Pt underwent mri t spine without contrast due to numbness & tingling.Impression: extensive postsurgical change is present within the lumbar spine with acute angle kyphosis centered at l1.Otherwise, mild degenerative disc disease is present within the lower thoracic spine.Pt underwent xr abdomen with chest due to nausea.Impression: trace right pleural effusion.Non-obstructive bowel gas pattern.On (b)(6) 2011: pt presented with abd pain, nausea, vomiting, numbness & tingling in her legs.Pt presented with following pre-op diagnoses: gastrointestinal bleeding, abd pain, intractable nausea & vomiting, with previous gastric bypass.Pt underwent esophagogastroduodenoscopy with biopsy & clipping.No complications reported.Post -op diagnosis: status post gastric bypass.Giant anastomotic ulceration just distal to the gastrojejunostomy, with oozing of blood identified.On (b)(6) 2011: pt underwent chest x-ray due to picc line insertion.Impression: picc line in the right atrium & it could be pulled back 4 cm.No pneumothorax.Pt underwent chest x-ray due to picc line placement.Impression: picc line in the distal superior vena cava.No pneumothorax.On (b)(6) 2011: pt was discharged with following discharge diagnosis: hypocalcemia, corrected.Decubitus ulcer.Large anastomotic ulcer.Ventricular bigeminy.History of gerd.History of bipolar disorder.History of chronic low back pain.History of copd.On (b)(6) 2011: pre-op diagnosis: history of anatomotic ulceration with hemorrhage & returns for follow up.Pt underwent esophagogastroduodenoscopy with biopsy.No complications reported.Post-op diagnoses: status post partial gastrectomy with an inflammation ulceration just distal to the anastomosis without evidence of visible vessel or active bleeding, clips identified, biopsies obtained.On (b)(6) 2012: pt presented for f/u evaluation to assess for healing with history of anastomotic ulceration.Pt underwent esophagogastroduodenoscopy with biopsy.No complications reported.Post-op diagnoses: anastomotic ulceration, mildly improved.Evidence of previous gastric bypass procedure.On (b)(6) 2012: pt presented with following pre-op diagnoses: abd distress.History of gastric ulceration.Pt underwent esophagogastroduodenoscopy with biopsy.No complications reported.Post-op diagnoses: large ulceration in the proximal stomach, possibly a gastroenterostomy.Otherwise negative upper exam.On (b)(6) 2012: pt presented with back pain.On (b)(6) 2012: pt underwent cta chest due to chest pain.Impression: positive for pulmonary thromboembolism.On (b)(6) 2012: pt underwent ct abdomen/pelvis with & without contrast due to abd pain.Impression: small right effusion.Lt.Renal cyst.Inferior vena cava filter.Previous gastric bypass.Mild dilatation common bile duct measuring 8.0 to 9.0 mm in maximum diameter.No significant intrahepatic biliary dilatation.No calcified gallstones are noted.On (b)(6) 2012: pt underwent vena cavagram due to history of pulmonary emboli as well as deep venous thrombosis.Impression: relatively unremarkable inferior vena cava showing extensive collateral vessels.No intraluminal thrombus is seen within the inferior vena cava at this time.Post surgical changes within the abdomen.No specific abnormalities are identified.Pre-op diagnoses: intense nausea & vomiting, history of known chronic gastric ulceration.Pt underwent esophagogastroduodenoscopy with biopsy.No complications reported.Post-op diagnoses: status post gastric partitioning with narrowed area in the proximal stomach with large ulceration.Rule out malabsorption.On (b)(6) 2012: pt underwent xr ugi with kub due to pain.Impression: postsurgical change consistent with the clinical history of partial gastrectomy & billroth anastomosis.In the mid portion of the stomach in the location of the anastomosis, there are findings felt to represent thickened mucosal folds with a persistent collection of barium, ulceration is considered.On (b)(6) 2012: pt was discharged with following discharge diagnoses: gastric ulcer.Pulmonary embolism.Deep venous thrombosis.Chronic pain syndrome.Stage 4 lumbar wound.Major depressive disorder.Anxiety disorder.8.Fibromyalgia.On (b)(6) 2012: pt underwent lumbar spine x-ray as pt fell.Impression: i do not detect any acute fracture or change in alignment at this time in this pt with marked post operative changes & deformity.Pt underwent hip x-ray.Impression: negative pelvis & lt.Hip.Pt underwent chest x-ray.Impression: port catheter present.Lungs clear.On (b)(6) 2012: pt underwent chest x-ray due to shortness of breath.Impression: right lower lobe infiltrate.Pt underwent chest x-ray post intubation.Impression: endotracheal tube in satisfactory position.Right lower lobe infiltrate & small effusion.On (b)(6) 2012: pt underwent xr abdomen for gi tube placement due to kub, nasogastric tube placement.Impression: nasogastric tube, proximal stomach.Pt underwent chest x-ray post intubation.Impression: endotracheal tube in satisfactory position.Right lower lobe infiltrate & small effusion.Pt underwent xr abdomen for gi tube placement due to nasogastric tube placement.Impression: nasogastric tube curled in the gastroesophageal junction with the tip extending proximally into the distal esophagus.Pt underwent xr abdomen for gi tube placement due to orogastric tube placement.Impression: orogastric tube extends into the proximal stomach.Preop diagnoses: acute renal failure.Aspiration pneumonia.Mucous plugs.Pt underwent bronchoscopy.No complications reported.Post-op diagnoses: copious amount of secretions & mucous plugs, removed from the right lower lobe.On (b)(6) 2012: pt presented with large wound dehiscence in the lumbosacral area with hypotension, coagulopathy.Pt underwent chest x-ray post intubation.Impression: mild chronic obstructive pulmonary disease changes.Tubular devices appear to be in good position.Pt underwent echocardiogram which showed ejection fraction 60-65%.On (b)(6) 2012: pt was discharged with following discharge diagnoses: acute respiratory failure.Acute exacerbation of chronic obstructive pulmonary disease.Right lower lobe pneumonia.Opiate dependence, probable overdose.Bipolar disorder.Urinary tract infection.Sacral wound.Medical noncompliance.Chronic pain syndrome.Personal history of pulmonary embolism.It was reported that per the autopsy report that the pt was found deceased on (b)(6) 2012.Per the report it was stated that cause of death was: acute combined toxic effects of methadone, hydromorphone, temazepam, clonazepam, promethazine & meprobamate.Manner of death was reported as accident.Per autopsy report - the thoracic & lumbar vertebrae have prominent osteophytes.Autopsy findings & diagnoses: presence of methadone, hydromorphone, temazepam, oxazepam, clonazepam, 7-aminoclonazepam, promethazine & meprobamate in blood.Lt.Lower lung lobe edema & congestion.Remote thrombi of bilateral branches of pulmonary artery.Right pleural fibrous adhesions.Pericardial effusion.Sparse, acute & chronic epicardial inflammation (histologic finding).Moderate to severe coronary atherosclerosis.Lt.Ventricular hypertrophy.Myocardial scar.Nephrosclerosis.Lt.Renal cyst.Remote infarct of lt.Basal ganglion.Status post remote gastric bypass surgery.Pigmented thyroid gland.Marked curvature of thoracic & lumbar spine.Port within lt.Subclavian vein.Filter within inferior vena cava.Edema of lower legs.Lt.Temporal subgaleal hemorrhage.Dehisced wound of back.(b)(6).(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.
 
Event Description
It was reported that on (b)(6) 2009: pt underwent chest x-ray due to shortness of breath.Impression: abnormal chest xray.Cardiomegaly, particularly for the pt's age.Blunting of the right costophrenic angle; this may be due to pleural scarring but the possibility of a right pleural effusion can not be excluded.On (b)(6) 2009: pt underwent lt.Lower leg x-ray due to pain, injury.Impression: no evidence of acute fracture.On (b)(6) 2009: pt underwent chest x-ray due to shortness of breath.Impression: overall, no major change from on (b)(6) 2009.Small amount of pleural fluid, reactive change or scarring at the right costophrenic angle.Prominent heart size for the pt's age although the pt does have a prominent transverse diameter in general.On (b)(6) 2009: pt presented with tremendous amount of back pain.Pt actually became worse last friday after third epidural steroid injection.The first two were beneficial, however, the last one created a problem for her.It caused shooting pain down the lt.Leg while he was doing the injection & now pt was having worsened back pain & her legs now had bilateral thigh pain.Pt was miserable & really wanted to proceed with surgery.On (b)(6) 2009: pt underwent chest x-ray due to asthma.Impression: no change from on (b)(6)2009.No evidence of acute disease in the chest.On (b)(6) 2009: pt presented with back pain, leg pain, was diagnosed with stenosis, spondylosis.Pt underwent xr fluoro non rad.Findings: no films, no dictation.Pt underwent lumbar spine x-ray status post spinal fusion.Impression: there are post-surgical changes from previous spinal fusion.Pre-op diagnoses: degenerative disk disease, spondylosis, stenosis, radiculopathy, instability, l3-4, l4-5, l5-s1.Pt underwent following procedures: bilateral microlaminectomies & extensive foraminotomies, l3-4, l4-5, l5-s1.Posterior lumbar interbody fusion, l3-4 using capstone interbody devices & locally harvested morcellized autograft.Posterior lateral arthrodesis using bone morphogenic protein & locally harvested morcellized autograft, l3-4, l4-5, l5-s1.Pedicle screw fixation, l3, l4 & l5 & s1.Procedure was carried out under fluoroscopic guidance.Per op notes, pituitary rongeur was used to clean out additional remnants of disk & capstone interbody device measuring 8 x 26mm was packed with locally harvested morcellized autograft, tamped & countersunk into place.In the case, one kit of bone morphogenic protein had been opened.Bone morphogenic protein was applied to the collagen sponge contained within the kit.The sponge was then cut in half.Locally harvested morcellized autograft was placed over each collagen sponge half & these were rolled into cylindrical shapes & placed laterally between the transverse processes of l3, l4 & l5 & the sacra ala bilaterally.Two rods were chosen for appropriate length.Four connectors were slid onto each rod.The connectors were slid down over the pedicle screws.No complications reported.On (b)(6) 2009: pt was discharged.On (b)(6) 2009: pt underwent lumbar spine x-ray due to pain.Impression: postoperative posterior fusion of the lower lumbar spine from l3 to s1.Pars defect at l5 with anterior spondylolisthesis of l5.On (b)(6) 2009: pt presented for post-operative f/u.Pt reported having bogginess in the upper part of the wound.Pt had some superficial exfoliation of some of the skin with some minor bruising where she had some tape on & was concerned because they stated that she was allergic to surgical tape.Pt stated that around 2:00 in the morning on (b)(6) 2009, pt went to get up from the toilet seat & developed a pop & excruciating pain in her lower back with numbness down both legs & pain.Pt stated that the numbness was back to being intermittent as it was before, but the back pain still bothered her.Pt was still having some intermittent pain down both legs.On (b)(6) 2009: pt presented for f/u.Pt's pain was better, although pt was still having some significant discomfort.On (b)(6) 2009: pt presented after falling in kitchen.Pt underwent lumbar spine x-ray due to back pain.Impression: there are post surgical changes involving the lower lumbar spine from l3 to s1.The pedicle screws are visualized connected bilaterally with metallic struts.A cross over piece is visualized at the l3-4 level.A prosthetic disc spacer is seen at l3-4.Laminectomy change is present involving l3, l4 & l5.There are multiple densities visualized over the upper abdomen representing post surgical change.The vertebral bodies, pedicles at l1-2 as 'hellas the lower thoracic spine appeared normal.No acute abnormality is seen.Comparing the current examination to a previous study of (b)(6) 2009, there is no significant change.The previously described pars defect at l5 is not as well seen in the current examination.On (b)(6) 2009: pt presented for physiatric evaluation & treatment with chief complaint of low back pain.Pt reported having low back pain across the lower back, bilateral leg pain, lt.Greater than right, described as dull, aching, intermittent, & exacerbated by standing & walking.Pt was found positive for insomnia, muscle pain, joint pain, stiffness, generalized fatigued, weakness.Musculoskeletal exam revealed moderate swelling in the bilateral lower extremities.Thoracolumbar palpation revealed moderate lumbosacral tenderness with minimal spasms over the lumbar paraspinal muscles bilaterally.On (b)(6) 2009: pt presented for post-operative f/u & evaluation of lumbar wound.Since surgery, pt had fallen three times.Pt still had back pain.There was watery discharge from the lowest part of the wound on palpation.There was some redness along the areas where the eschar was.On (b)(6) 2009: pt presented with pre-op diagnosis of possible lumbar wound infection.Pt on (b)(6) 2009: pt underwent chest x-ray due to picc line placement.Impression: bibasilar infiltrates.Elevation of the lt.Hemidiaphragm.Right arm picc line ends in the distal superior vena cava.Pt underwent right knee x-ray due to right knee pain.Impression: no acute bony injury right knee.Degenerative changes.Soft tissue swelling along the medial aspect of the right knee.Pt underwent lt.Knee x-ray due to lt.Knee pain.Impression: no acute bony injury, lt.Knee.Degenerative changes.On (b)(6) 2009: pt underwent cta chest with & without contrast due to shortness of breath.Impression: bibasilar infiltrates, lt.Greater than right.Trace right pleural effusion.No evidence of pulmonary embolism.On (b)(6) 2009: pt underwent chest x-ray due to pe.Impression: no radiographic evidence of acute cardiopulmonary process.Persistent elevation of the lt.Hemidiaphragm.Bibasilar hypoventilatory changes.On (b)(6) 2009: pt was discharged.On (b)(6) 2009: pt presented for wound check.Pt continued to drain quite a bit of fluid from the lumbar wound site.It was clear & at times mucous drainage, cream-colored to brown-tinged.Pt continued to have a lot of back pain.Wound was erythematous.On (b)(6) 2009: pt was admitted with intractable back pain.On (b)(6) 2009: pt was admitted with following diagnoses: lumbar infection, low back pain, lower extremity weakness & paresthesia.Pt underwent chest x-ray due to shortness of breath.Impression: persistent congestive failure, unchanged since previous examination.On (b)(6) 2009: pt underwent mri lumbar spine with & without contrast due to lower extremity weakness after surgery one week prior.Impression: mild to moderate stenosis at the l2-3 level.There is suggestion of possible posterior epidural hematoma & epidural fat compressing upon the thecal sac.This region measures 8.0 mm in ap diameter & 2.2 cm in its superior to inferior extent.Correlation with preoperative films would be extremely helpful.Orthopedic consultation is strongly suggested.Transpedicular screws in the l3, l4, l5 & s1 vertebral bodies due to post -surgical artifact.Small central disc protrusion at the l4-5 level.Note is made of infiltration in the subcutaneous soft tissues posterior to the l2 vertebral body with some ill-defined fluid in the subcutaneous region.A discrete abscess collection is not identified.On (b)(6) 2009: pt underwent rt upper quadrant sonogram due to pain.Impression: hepatomegaly.Dilated common bile duct.Pt was discharged with following discharge diagnoses: postoperative infection, disruption of external operation wound,hematoma, complicating procedure, bipolar i disorder, lumbago, other chronic pain, chronic obstructive asthma, pseudomonas infection, anemia, hypokalemia, hyperlipidemia, tobacco use disorder, esophageal reflux, arthrodesis status post bariatric surgery.On (b)(6) 2009: pt underwent chest x-ray due to picc line placement.Impression: lt.Picc catheter tip in the mid right superior vena cava.Linear atelectasis versus scarring at the right lung on (b)(6) 2009: pt presented for f/u.Wound was still draining from the lower part of the wound but it looked more like a serosanguineous, might be even break down of fat tissue.There was no foul odor.On (b)(6) 2009: pt was discharged with following discharge diagnoses: l3-s1 fusion, (b)(6) 2009.Postop wound infection with incisional dehiscence & status post incision & drainage, (b)(6) 2009.Bipolar disorder.Fibromyalgia.Chronic obstructive pulmonary disease with asthma.Obesity.Status post roux-en-y.Gastroesophageal reflux disease.On (b)(6) 2009: pt presented with low back pain described as constant, aching, sharp, & radiating intermittently to the bilateral legs currently more to the lt.Side.Pt reported that back pain was exacerbated by sitting & walking & was relieved by laying down.Neck was supple.Assessment: low back pain status post lumbar wound infection, incision, & drainage, currently on iv antibiotic therapy status post lumbar fusion in (b)(6) 2009.On (b)(6) 2009: pt presented for post-op f/u with pain & swelling in her legs.On exam, pt had significant pitting edema in both lower extremities.Both legs demonstrated popliteal tenderness.Pt had relatively superficial wound infection.On (b)(6) 2009: pt presented for post-operative f/u.Pt was having pain in right lower back area.Pt was still having vacuum pump in her back at her wound which was healing up very nicely.Examination revealed pt having generalized giveaway in both lower extremities.On (b)(6) 2009: pt presented for reassessment of pain management.Pt reported having moderate to moderately severe low back pain & intermittent bilateral neck pain mainly exacerbated when moving around up to a level of 7/10 or 8/10.Pt described her pain as dull, aching.Pt was found positive for fatigue, generalized weakness, anxiety & depression.Assessment: low back pain status post lumbar fusion with gradual improvement in pain control.On (b)(6) 2009: pt presented for f/u.Pt was doing better & her pain was diminishing.Examination revealed that her wound continued to heal up nicely.On (b)(6) 2010: it was reported through phone call that the pt was having severe low back pain due to riding in the car.On (b)(6) 2010: it was reported through phone call that the pt was in pain & prescribed hydrocodone was not working.On (b)(6) 2010: pt presented for f/u & underwent lumbar spine x-ray.Impression: status post interbody fusion l3-4.Pedicle screw fusion l3 to s1.Mild retrolisthesis of l2 on l3.No abnormalities identified pertaining to the pedicle screws or posterior fusion hardware.On (b)(6) 2010: pt presented with increasing back pain & brace/collar fitting.Assessment: pt still had a small open area on her incision.Diagnosis: lumbar radiculopathy secondary to stenosis & degenerative disc disease.On (b)(6) 2010: pt underwent lumbar spine x-ray due to increasing back pain.Impression: solid fusion, l3 to s1.Retrolisthesis of l2 on l3.On (b)(6) 2010: pt underwent ct lumbar spine without contrast due to increasing back pain.Impression: there has been fusion from the l3 to the s1 vertebrae.This is with pedicular screws as well as posterior rods.There is also an intervertebral disc device present at the l3-4 level.The pedicular screws extend satisfactorily into the vertebral bodies at l3, l4, & l5 as well as s1.However, at the l3 level there are fractures of the pedicles bilaterally with the superior aspect of the pedicles displaced from the pedicular screws.There is also a small chip-like fracture off the superior posterior end plate of the l3 vertebra.There is subluxation at the l2-3 interspace with the l3, l4, l5 & s1 vertebral bodies that are fused anteriorly subluxed to the l2 vertebra.The subluxation secondary to the bilateral pedicular fractures is approximately 7-8 mm of subluxation.This would result in spinal stenosis at this level.The l4, l5, & s1 pedicular screws are in good position.No pedicle fractures are noted.The t11 through l2 vertebrae show anatomical alignment in regards to respective vertebral bodies.The posterior elements are intact.Reformatted sagittal as well as coronal images show the subluxation at the l2-3 level as well as the fractures of the pedicles & the superior posterior end plate of the l3 vertebra.Pt underwent lumbar spine x-ray due to increasing back pain.Impression: l2-3 retrolisthesis again noted; limited motion.No evidence of instability.On (b)(6) 2010: pt underwent mri lumbar spine without contrast due to back pain.Impression: posterior spinal fusion l2 through s1.Abnormal signal within the vertebral bodies may reflect edema rather than infection at the l2, l3, & s1 vertebral bodies.No discitis can be identified.Moderate canal stenosis suggested at the l2-3 level.Abnormal fluid collection within the soft tissues posterior to the spinal elements may reflect post surgical change related to either hematoma or seroma.Infection cannot be excluded as there is air within it & this may suggest communication with in the skin surface.Pt reported through phone call that she in pain.On (b)(6) 2010: pt underwent lumbar spine x-ray due to check line placement.Impression: there is a right subclavian picc catheter with its tip projecting in good position.No active cardiopulmonary disease is seen.On (b)(6) 2010: pt presented with severe back pain.Pt underwent lumbar spine x-ray due to low back pain.Impression: there are post surgical changes from posterior spinal fusion from l4 down to s1.Pt underwent xr fluoro non rad.Findings: no films, no dictation.Pre-op diagnoses: fracture, l3.Unstable retrolisthesis, l2 on l3.Status post previous fixation/fusion, l3-l4, l4-l5 & l5-s1.Pt underwent following procedures: hardware removal, l3-l4, l4-l5 & l5-s1.Bilateral microlaminectomies & extensor foraminotomies, l2-l3.Posterolateral arthrodesis using bone morphogenic protein & locally harvested morcellized autograft, l1-l2, l2, l3-l4, l4-l5 & l5-s1.Pedicle screw fixation, l1, l2, l4, l5 & s1.Per op notes, hardware was then removed by first removing a crosslink.The top-tightening screws of the connectors were then removed, followed by removal of the rods.The connectors were then removed as well.The pedicle screws at l3 were noted to be loose as this was the level of the fracture.The pedicle screws were then all removed.The s1 pedicle screws were noted to be loose as well, especially on the right where the pt had a fracture of the superior pedicle.The c-arm was brought in & placed in anteroposterior position.Due to the fracture at l3, it was elected not to replace the pedicle screws at that level but to carry the construct up to l1.Earlier in the case, two kits of bone morphogenic protein had been opened.Bone morphogenic protein was applied to the collagen sponge contained within each kit.Locally harvested morcellized autograft was placed over the resulting four collagen sponges.These were then rolled into cylindrical shapes & placed end-to-end so as to span between the transverse processes of l1, l2, l3, l4, l5 & the sacral ala bilaterally.No complications reported.On (b)(6) 2010: postoperative day # 4, the pt stated that she had been walking the day prior & "felt a pop".Pt underwent lumbar spine x-ray.Findings: pedicle screws are seen at s1, l5 & l4 & then in l2 & l1.Low back fusion is seen in this region.Broad laminectomy is noted.There are several millimeters of retrolisthesis of l2 on l3.On (b)(6) 2010: it was reported through call that the pt was having lots of burning pain in her back & she could not get her back brace.Pt was advised to continue medication.On (b)(6) 2010: pt presented for post-op f/u.Pt was having difficult postoperative course.Pt mentioned that she had a burning dysesthetic pain that felt like acid was being poured over her abdomen, pelvis & thighs all the way back around into the buttocks.This seemed to have resolved.She felt this mostly with wearing tight-fitting clothes.Wound exam revealed that lumbar wound had healed nicely.On (b)(6) 2010: pt presented for post-op office visit.It was reported that her wound was leaking.Pt was quite tearful.Pt looked fatigued & disheveled.Pt was ambulating with walker.Wound review revealed that the area was palpated & there were no indurated areas or painful areas surrounding incision.Pt underwent lumbar spine x-ray due to l3 fracture.Impression: comminuted fracture of the l1 vertebral body with pedicle screws having backed out of the vertebral body somewhat since (b)(6) 2010.Top of the part of the fixation bar & screws appear to be projecting below the level of the soft tissue.On (b)(6) 2010: pt underwent mri thoracic spine without contrast due to back pain.Impression: postsurgical change noted at the l1 vertebra with pedicular screws & rods with subsequent fusion to the sacrum as noted on previous lumbar spine.Unremarkable mri examination of the thoracic spine.No spinal stenosis is seen.No compression deformity &/or extradural defects to suggest herniated nucleus pulposus.Pt underwent mri lumbar spine with & without contrast due to new l1 fracture.Impression: reverse spondylolisthesis of l2 on l3 that appears stable & unchanged since previous examination.Since previous examination there has been fusion from l1 through s1.Previously it was l3 through s1.There is a large extradural defect noted at the l2-l3 interspace posteriorly secondary to the reverse spondylolisthesis both causing disc compromise of the thecal sac & mild to moderate spinal stenosis at this level secondary to the reverse spondylolisthesis & posterior disc osteophyte complex.No other acute abnormalities noted.No definite epidural abscesses or epidural hematoma or other abnormalities noted.No other abnormalities seen.On (b)(6) 2010: pt underwent densitometry which was performed in the hips & lt.Forearm.Impression: the pt has osteoporosis.The pt's bone mineral density is 2.8 standard deviation (s) below the mean bone mineral density of sex & race matched health adults at peak bone mass.Pt requested through call regarding changing her medicine from percocet to oxy ir.On (b)(6) 2010: pt presented for f/u.Pt's wound was healed.On (b)(6) 2010: pt underwent chest x-ray due to central line placement.Impression: right jugular central line positioned in the mid superior vena cava, no evidence of pneumothorax or other acute abnormality.Pre-operative diagnosis: l1 fracture with loose hardware.Pt underwent following procedures: removal of hardware, l1, l2, l4, l5, & s1.2.Onlay fusion using bone morphogenic protein & mastergraft, l1-2, l2-3, l3-4, l4-5 & l5-s1.Per op notes, hardware was then removed.The cross link was removed first.Next, the top-tightening connector screws were removed.The two rods were removed followed by the connectors, & finally the pedicle screws at l1, l2, l4, l5, & s1 were removed.The pt had no pedicle screws at l3.The transverse processes of t12, l1, l2, l3, l4, l5, & the sacral ala were decorticated bilaterally.Earlier in the case, two kits of bone morphogenic protein had been opened.Bone morphogenic protein was applied to the collagen sponge within each kit, & the sponges were then cut in half, resulting in a total of four sponges.Mastergraft was placed over each collagen sponge.These were then rolled into cylindrical shapes.Two sponges were placed end to end on the right & two on the lt.Side, spanning between the transverse processes of t12 & the sacral ala.No complications reported.Post-op diagnoses: l1 fracture with loose hardware; superficial wound infection.On (b)(6) 2010: pt underwent chest x-ray due to picc line placement.Impression: lt.Picc tip in the distal superior vena cava.Right internal jugular catheter in place with the tip in the distal superior vena cava.No pneumothorax.On (b)(6) 2010: it was reported through call that pt's back was draining & it was not slowing down & was getting worse.It was yellow with blood but no odor.On (b)(6) 2010: pt called & reported severe pain.Pt was crying & was upset & asked for stronger medicine.On (b)(6) 2010: pt underwent mri lumbar spine with & without contrast due to back pain.Impression: status post removal of hardware from extensive bilateral posterior pedicle screw & metal rod fusion; there is a comminuted fracture to the body of l1 with diffuse marrow edema.Marrow edema is also present at l2 & l3, which could be reactive due to the pedicle screw or could be inflammatory.Similar changes are seen along the superior endplate of s1.There is narrowing of the ap dimension of the spinal canal behind l1 & also behind the l2-l3 disc level due to the rather marked retrolisthesis of l2 in relation to l3.There is considerable granulation tissue present posterior to the lumbar spine & there is elongated serpiginous fluid collecting tracking down the entire length of the paraspinous soft tissues behind the lumbar region, which certainly could be infected.This involves the paraspinous musculature bilaterally & the sub-q soft tissues in the midline.Pt underwent lumbar spine x-ray due to back pain.Impression: removal of the pedicle screw infusion rods with a comminuted fracture of the l1 vertebral body.At least 1 cm of retrolisthesis of l2 with respect to l3.Bone graft & laminectomy material again noted.On (b)(6) 2010: pt was discharged with following discharge diagnosis: lumbar wound infection.Status post removal of hardware & abscess drainage just last week.Anemia.Hypoalbuminemia.Anasarca which improved.History of gastric bypass.Osteoporosis.Fibromyalgia.Bipolar disorder & depression.On (b)(6) 2010: pt presented for post operative f/u.Pt was having her wound packed on daily basis.Pt was in moderate amount of distress & was ambulating extremely slow.Examination of wound revealed that the top part of the wound was healing well.On (b)(6) 2010: pt underwent sp venous access procedure as pt no longer needed the picc; picc removal.Impression: successful lt.Picc removal by special procedures technologist (b)(6).On (b)(6) 2010: pt presented for post operative f/u.Assessment: satisfactory postoperative course.On (b)(6) 2010: pt underwent lumbar spine x-ray.Impression: little change in the alignment, subluxation & fractures of the upper lumbar spine as described, when compared to (b)(6) 2010.On (b)(6) 2010: pt presented for evaluation.Pt underwent chest x-ray due to chest pain.Impression: blunting of the right costophrenic angle.Pt underwent cta chest with & without contrast.Impression: positive study for pulmonary emboli in the proximal lt.Lower lobe branch arteries.Resolved bibasilar infiltrates with residual right pleural thickening & right basilar scarring.Mild emphysema.On (b)(6) 2010: pt underwent chest x-ray due to picc line placement.Impression: picc line at the junction of the superior vena cava & right atrium.On (b)(6) 2010: pt was discharged with following discharge diagnosis: pulmonary embolism.Chronic low back pain with history of recurrent lumbar surgeries.Chronic postop lumbar wound.Fibromyalgia.Hypertension.Bipolar disorder.On (b)(6) 2010: pt presented status post hardware removal l1 to s1.After being admitted, she was found to have pulmonary embolus & fungal wound infection.On (b)(6) 2010: pt underwent lumbar spine x-ray.Impression: post surgical changes.There is fracture involving the inferior posterior aspect of the l1, this has been mentioned previously.There is forward displacement of l3 with respect to l2.There are degenerative changes.On (b)(6) 2010: pt presented for post operative f/u.On (b)(6) 2010: pt underwent myocutaneous rotational flap closure of her chronically diseased lumbar surgical wound.
 
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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
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5049249
MDR Text Key25257584
Report Number1030489-2015-02166
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
Reporter Occupation Attorney
Report Date 08/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/01/2011
Device Catalogue Number7510800
Device Lot NumberM110810AAD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/03/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/29/2009
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 Weight98
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