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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 7510400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Scarring (2061); Burning Sensation (2146); Tingling (2171); Cramp(s) (2193); Discomfort (2330); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
Event Type  Injury  
Event Description
It was reported that the patient underwent a posterior lumbar interbody fusion ("plif") at l5-s1 using rhbmp-2/acs and a cage made of polyetheretherketone.A posterior lumbar fusion was also performed at the same levels.Reportedly, sometime following surgery, the patient followed up with her physician.She began to develop radiating pain in her back and legs.The patient continues to experience daily, disabling pain that prevents her from performing many activities of daily living.
 
Manufacturer Narrative
Concomitant product: cage (implant (b)(6) 2008).(b)(4).Neither the device nor applicable imaging study films or patient medical records 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/used 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) 2003, (b)(6) 2003, (b)(6) 2003, (b)(6) 2004, patient presented for office visit.(b)(6) 2004, patient underwent following procedure: 1.Right l5 epidural steroid injection and myelogram.(b)(6) 2004, (b)(6) 2004, patient underwent following procedure: 1.Right l5 epidural steroid injection and myelogram, 2.Right l5 facet and sacroiliac joint injection.(b)(6) 2005, patient presented for office visit.(b)(6) 2006, patient fell on (b)(6) 2006 and injured her fibula.Examination showed tenderness in distal fibular area.X-rays showed spiral non-displaced fracture of the fibula.(b)(6) 2006, patient underwent x-ray of ankle which showed no dislocation.(b)(6) 2007, (b)(6) 2007, patient presented with complaint of back pain radiating down right leg.(b)(6) 2007, patient underwent x-ray of chest.Impression: normal.(b)(6) 2007, patient presented with complaint of low back pain.(b)(6) 2007, patient presented with complaint of increased cramping in right leg.(b)(6) 2008, (b)(6) 2008, patient presented for office visit for low back pain.(b)(6) 2008: patient presented for follow-up for back pain radiating down leg.(b)(6) 2008, patient underwent x-ray of chest.Impression: negative chest.(b)(6) 2008, (b)(6) 2008, (b)(6) 2008, (b)(6) 2008, patient presented for office visit for back pain radiating down leg.(b)(6) 2009, patient presented for follow-up with chief complain of increasing low back pain.(b)(6) 2009, (b)(6) 2009, patient presented for follow-up for low back pain.(b)(6) 2009, patient presented for follow-up.(b)(6) 2010, patient presented for follow-up visit and reported back pain with cramping in calves.(b)(6) 2010, (b)(6) 2011, patient presented for follow-up visit and reported back pain which increases with activity.(b)(6) 2011, patient presented for follow-up visit and reported increasing back pain which radiates down right leg.(b)(6) 2013, (b)(6) 2013, patient presented for follow-up on ongoing back pain.(b)(6) 2014, patient presented for office visit for recurrent low back pain radiating into right lower extremity.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on (b)(6) 2003: the patient underwent mri of the lumbar spine.Impressions: status post removal of right "lparacentral" disc protrusion with mild epidural scarring surrounding the right s1 nerve rootlet.On (b)(6) 2005 the patient underwent mri study revealing l5-s1 disc herniation.The patient was also presented for office visit with pe rsistent pain in her lower back.Impressions: radiculopathy.On (b)(6) 2005 the patient was presented for office visit with pain in her lower back down both legs.On (b)(6) 2005 the patient was presented for office visit with pain, numbness and tingling in her lower back.On (b)(6) 2005 the patient underwent right l5-s1 lumbar discectomy under microscope.On (b)(6) 2005: the patient was presented for office visit with mild discomfort in her back and tightness in the back.On (b)(6) 2005: the patient was presented for office visit with pain in the left leg from the hip down the leg posterolaterally to the foot.On (b)(6) 2006 the patient was presented for office visit multiple areas of pain including inher neck, arms, hands and her lower back.On (b)(6) 1998: patient presented for an office visit.On (b)(6) 1998: patient presented for an office visit for recheck on her right forearm.On (b)(6) 1998: patient presented for an office visit.Patient presented with pain in the thumb that radiates to the forearm.On (b)(6) 1998: patient presented for an office visit.On (b)(6) 1998: patient presented for an office visit.Assessment: gastroentertitis.On (b)(6) 1998: patient presented for an office visit.Patient presented with some tenderness and little bit of fullness and tight sensation in the forearm.On (b)(6) 1998: patient presented for an office visit.Patient presented with pain in the mcp joint.On (b)(6) 2002: patient underwent x-ray of the chest region.Findings: heart is normal in size.Lungs are clear.On (b)(6) 2004: patient underwent mri of lumbar without contrast.Impression: moderate right paracentral disc protrusion at the l5/s1 l evel.On (b)(6) 2006: patient underwent chest x-ray.Impression: negative chest x-ray.On (b)(6) 2009 the patient underwent x-ray of lumbar spine.Findings: there had been plate screw fixation of the level l5-s1.The remaining levels are unremarkable without evidence of acute fracture.On (b)(6) 2011: patient presented for an office visit.Impression: chronic low back pain, status post herniated disk protrusion, postoperative microdiskectomy, postoperative fusion laminectomy, chronic low back pain, radicular pain into the legs.The patient had a concomitant anxiety and depression history that compounds the situation in a chronic pain syndrome.On (b)(6) 2014, (b)(6) 2015: as per the record patient underwent x-ray of the chest.Impression: no acute finding.
 
Manufacturer Narrative
Add'l info: (b)(4).
 
Event Description
It was reported that (b)(6) 2003: patient underwent chest x-ray.Impression: no active disease.No change since previous examination of (b)(6) 2002.On (b)(6) 2003: patient sustained workplace injury.The injury involved the neck, upper back and lower back.The injury resulted from lifting and this occurred when the patient and another worker were lifting an invalid student.Assessment: a.Lumbar sprain.B.Sciatica.On (b)(6) 2003, (b)(6) 2004, (b)(6) 2005: the patient presented for follow up for her lumbar strain, herniated disk, and another diagnosis.Assessment: bulging disc (l5 - s1).Lumbar strain.Neck strain.Thoracic strain.On (b)(6) 2003: patient presented for recheck of her back with increasing pain on her right side.Assessment: lumbar strain.Neck strain.Thoracic strain.On (b)(6) 2003: patient presented for recheck for her thoracic and lumbar sprain.On (b)(6) 2003: patient underwent mri of lumbar spine without contrast.Impression: moderate right paracentral disc protrusion at the l5/s1 level.On (b)(6) 2004: patient presented for back and right leg pain.Impression: right s1 radiculopathy secondary to disc herniation; right l5 facet hypertrophy with secondary foraminal stenosis; history of several positive waddell signs; history of tobacco abuse, diabetes mellitus, obesity, anxiety and antibiotic allergy.On (b)(6) 2004: patient underwent chest x-ray due to positive ppd.Impression: radiographically stable unremarkable single view chest x-ray examination.On (b)(6) 2004: patient presented with back and leg pain.On (b)(6) 2005: patient underwent mri of lumbar spine without contrast.Impression: minimal improvement in a moderate sized right paracentral disc protrusion from (b)(6) 2003.The remaining intervertebral disc spaces are unremarkable and unchanged from prior.S1 nerve root displacement.On (b)(6) 2005 the patient underwent mri study revealing l5-s1 disc herniation.On (b)(6) 2005: patient presented with increasing pain across her lower back, spasms in her lower back and legs.On (b)(6) 2005: patient underwent chest x-ray.Impression: negative chest.On (b)(6) 2005 as per medical records, in physical examination percussion and palpation revealed mild discomfort in the lower thoracic to the lumbar area.On (b)(6) 2005: patient presented for pre-op evaluation and follow up on back.Assessment: bulging disc (l5 - s1).Lumbar strain.Neck strain.Thoracic strain.Patient underwent chest x-ray.Impression: negative chest.On (b)(6) 2005: patient underwent chest x-ray.Impression: negative chest x-ray.On (b)(6) 2006: the patient presented with fractured fibula and follow up care.On (b)(6) 2006: patient underwent right ankle x-ray.Findings: there is a minimally displaced oblique fracture of the distal fibula extending down to the lateral malleolus.No other fracture or dislocation is seen.The examination is performed through cast material.No prior exam is available for comparison.On (b)(6) 2006: patient underwent mri of lumbar spine with and without contrast.Impression: status post removal of right paracentral disc protrusion with mild epidural scarring surrounding the right s1 nerve rootlet.No recurrent disc protrusion is seen.On (b)(6) 2006: the patient presented with fractured fibula and follow up care.On (b)(6) 2006: patient presented for follow up for work related injury.The patient is complaining problems of back pain, neck pain, and difficult time squatting down while doing work at her place of employment when she was on limited duty.Assessment: major depression, single episode.Bulging disc (l5 - s1).Bulging intervertebral disc.Lumbar strain.Neck strain.Thoracic strain.On (b)(6) 2006: patient presented for follow up.Impression: lateral malleolus fracture.Patient underwent right ankle x-ray.Findings: since (b)(6) 2006, there has been no significant change in the alignment of the oblique fracture of the distal fibula.Obvious callus formation is not seen at this time.The examination is performed through cast material.No dislocation is seen.On (b)(6) 2006: patient presented for follow-up for her back and herniated disc.Assessment: bulging disc (l5 - s1).Lumbar strain.Neck strain.Thoracic strain.On (b)(6) 2006: patient presented for follow up for increasing pain in her left ribcage.Assessment: bulging disc (l5 - s1).Lumbar strain.Neck strain.Thoracic strain.On (b)(6) 2006: patient underwent mri cervical without contrast.Impression: no evidence of disc bulge or herniation.Minimal des iccation at the c6/7 level.On (b)(6) 2006: patient underwent right ankle x-ray.Findings: most recent prior available for comparison dated (b)(6) 2006.Cast has been removed.There has been near complete healing of previously described distal fibular fracture.Symmetry is maintained in ankle mortise.On (b)(6) 2006: patient underwent chest x-ray.Impression: negative chest x-ray.On (b)(6) 2006: patient presented for follow up for work related injury.The patient is complaining of dizziness and stuttering with taking the effexor.Patient was complaining of increasing pain at her back because of doing a lot of scrubbing motions on tables, trying to get glue off according to the patient.Assessment: major depression, single episode.Bulging disc (l5 - s1).Bulging intervertebral disc.Lumbar strain, neck strain.Thoracic strain.Schmorl's nodes of the lumbar region.Schmorl's nodes of the thoracic region (b)(6) 2006: patient presented for follow up.Patient was having some increasing numbness and tingling in her lower extremity that comes and goes.Patient felt like her lower back was very tight, and needed to be stretched.Assessment: major depression, single episode.Bulging disc (l5 - s1).Bulging intervertebral disc.Lumbar strain.Neck strain.Thoracic strain.On (b)(6) 2007: patient presented for pain management.Patient had three sessions of chiropractic manipulation.The numbness in her hands and arms has decreased over the last several weeks.Her worse pain in 8/10, where 10 is the worst pain she has ever experienced, it will drop to 5/10 when she is feeling the best.Patient described her pain as constant, sharp, dull, throbby, achy, and stabbing depending upon what her activity level was.Patient still complained of numbness and tingling and charley horses at night.This would wake her up.The patient had pain with knee flexion over the lumbar spine.Assessment: major depression, single episode.Bulging disc (l5 - s1).Bulging intervertebral disc.Lumbar strain.Neck strain.Thoracic strain.On (b)(6) 2007, (b)(6) 2008, (b)(6) 2009, (b)(6) 2010, (b)(6) 2011: patient presented for follow up with increasing pain in the lower back down the right leg.Assessment: major depression, single episode.Bulging disc (l5 - s1).Bulging intervertebral disc.Lumbar strain.Neck strain.Thoracic strain.On (b)(6) 2007: patient presented with increase in cramping in the right leg.Patient was also complaining of increasing cramping in the right leg but it also occurred in the left.She also got numbness in the right leg.Assessment: major depression, single episode.Bulging disc (l5 - s1).Bulging intervertebral disc.Lumbar strain.Neck strain.Thoracic strain.On (b)(6) 2007: patient underwent chest x-ray which was normal.On (b)(6) 2007: patient underwent mri of lumbar spine with and without contrast.Impression: postsurgical changes of laminectomy at the level of l5-s1 on the right side with mild epidural scarring in this region.No recurrence of disc herniation.A small, bulging disc at l5-s1 level.No significant change since prior exam of (b)(6) 2006.On (b)(6) 2007: patient presented with pain in the lower back with a pressure sensation.Patient had numbness and tingling in both legs, right greater than left.Assessment: bulging disc (l5 - s1).Bulging intervertebral disc.Lumbar strain.Neck strain.Thoracic strain (b)(6) 2007: patient presented for neurological consultation with chief complaint of back and right greater than left leg pain.Patient was also complaining of pain going into the arms as well as numbness.Nerve study was normal.She also complained of headaches, neck pain, thoracic pain and low back pain.She complained of her legs buckling.Review of systems revealed some weight loss, overall weakness, fatigue, change in taste, racing heart, nausea, numbness.Impression: failed back surgery.Chronic pain behavior with depression and anxiety.History of tobacco abuse, excess weight, hypertension, chronic obstructive pulmonary disease, diabetes mellitus, headaches, whole body pain.On (b)(6) 2008: patient presented for the result of drug screening.Patient had marijuana show up in her drug screen.Assessment: lumbar strain; bulging disc (l5 - s1).On (b)(6) 2008: patient presented with ongoing numbness, tingling and burning down both legs.Patient was complaining of increasing muscle spasms in the left calf.She also had numbness and tingling and burning down the left leg - greater than the right.Assessment: major depression, single episode.Bulging disc (l5 - s1).Bulging intervertebral disc.Lumbar strain.Neck strain.Thoracic strain.On (b)(6) 2008: patient presented for follow up with pain.It was reported that patient was under a lot of stress - stating that her pain was not under as good control as it was previously.Assessment: neck strain; lumbar strain; bulging disc (l5 - s1); major depression, single episode.On (b)(6) 2008: patient presented with increasing pain in the right lumbar area.Assessment: neck strain; lumbar strain; bulging disc (l5 - s1); major depression, single episode.(b)(6) 2008: patient presented with increasing pain and burning sensation down the right leg and pain in the right fifth digit of the foot.Patient experienced sharp pain while leaning back that shot up her back and than a burning sensation down her right lower extremity.It was difficult to sit or stand.She complained of constant burning.She had epidurals two weeks earlier.She stated that she had some improvement after the epidural shot for the first week or so.She stated that her right leg gave out and she fell and struck her right foot on a piece of furniture recently.She thought she had broken the right fifth digit.Patient had a difficult time trying to work with the toe situation as well as the burning sensation going down the right leg.Assessment: neck strain; thoracic strain; lumbar strain; bulging disc (l5 - s1); bulging intervertebral disc.On (b)(6) 2008: patient underwent mri of lumbar spine with and without contrast.Impression: previous right laminectomy at l5-s1.The epidural scarring at the l5-s1 level has worsened since the previous examination of (b)(6) 2007.It now encases the right s1 nerve root as it arises from the thecal sac and produces some impingement upon the right side of the thecal sac.Diffuse disk bulging with hypertrophic endplate change and overlying central disk extrusion at l5-s1.The disk extrusion produces only mild thecal sac impingement due to ample size of the canal at this level.Moderate right foraminal narrowing and mild left foraminal narrowing at l5-s1.On (b)(6) 2008: patient presented with ongoing pain down the right lumbar spine and leg.Patient still had significant pain on the right side of her lumbar spine going down the back of the leg.She described it as a burning sensation especially when she raises her right leg.She's had increasing pain where she had vomited twice.Patient underwent mri which indicated increased scarring from the previous mri of (b)(6) 2007 which is now encasing the right s1 nerve root and impingement on the right side of the thecal sac.There is also overlying central disk extrusion at l5-s1.Assessment: neck strain; thoracic strain; lumbar strain; bulging disc (l5 - s1).On (b)(6) 2008: patient underwent x-ray of chest.Impression: negative chest.On (b)(6) 2008: patient presented for orthopedic evaluation.Impression: recurrent disc protrusion l5-s1.On (b)(6) 2008: the patient presented with back pain due to lumbar fusion.On (b)(6) 2008: patient presented for pre-op evaluation with lightheadedness, dizziness and shortness of breath.Assessment: shortness of breath; lower back pain radiating to the legs bilateral; r>l; lightheadedness; lumbar strain; bulging intervertebral disc; bulgi ng intervertebral disc; bulging lumbar disc; bulging disc (l5 - s1); macrocytic anemia.On (b)(6) 2008 the patient underwent mri which showed a previous laminectomy at l5-s1, epidural scarring at l5-s1, and disc bulging at l5-s1 with foraminal narrowing.On (b)(6) 2008: patient underwent chest x-ray.Findings: comparison to (b)(6) 2008.Heart remains normal in size.Lungs are clear.Comparing to prior exam no significant interval change identified.On (b)(6) 2008: patient presented for a preoperative physical examination and reported pain in lower back.Assessment: major depression, single episode.Bulging disc (l5 - s1).Bulging intervertebral disc.Lumbar strain.Neck strain.On (b)(6) 2008: patient was reported being treated for anemia.Patient's pain was increasing.Assessment: major depression, single episode.Bulging disc (l5 - s1).Bulging intervertebral disc.Lumbar strain.Neck strain.On (b)(6) 2008: patient underwent chest x-ray.Findings: heart is normal in size.No acute pulmonary consolidation or pleural effusion.Comparing to prior exam, no significant interval change identified.(b)(6) 2008: patient presented with intractable back and right greater than left lower extremity pain, failing conservative therapy.Patient presented with difficulties and having failed conservative care and treatment with progressive and persistent pain.Preoperative diagnosis: l5-s1 herniated disk - protrusion with associated right leg radiculopathy.Patient underwent following procedures:lumbar reexploration, right l5-s1.Laminectomy.Extensive decompression.Right facetectomy with extensive diskectomy, l5-s1, with insertion of peek cage with rhbmp-2/acs (8 mm x 26 mm) with posterior lumbar intervertebral graft utilizing autologous bone with use of the operating microscope.Per op notes, the decompression was excellent and preparation of the endplates was accomplished.Measurements were taken without any nerve root impingement was a decompressed l5-s1 nerve root was checked with a right angle nerve hook and the 8 x 26 cage was now packed with rhbmp-2/acs and autologous bone products and lamina and facet stripped to soft tissue, morcellized with morcellized bone and a strip of rhbmp-2/acs placed medially in a tight morcellized fashion, compacted with a large curet and the nerve root retracted.The intervertebral cage was now placed in the disk space uneventfully, paramedially with autologous bone placed laterally.There were no electrophysiologic changes.Imaging was satisfactory as noted.No complications reported.Postoperative diagnosis: l5-s1 herniated disk - protrusion with associated radiculopathy with extrusion and extensive scar and nerve root adhesions.Gross findings: dense scar, nerve root adhesions, extruded disk l5-s1 with spondylosis.2nd part of the surgery - preoperative diagnoses: disk protrusion l5-s1.Patient underwent following procedures: posterior spinal fusion and instrumentation at the l5-s1 level utilizing polyaxial legacy instrumentation.Rhbmp-2/acs bone morphogenic protein for the posterior fusion part of the procedure at the l5-s1 level.Continuous running emgs as well as sseps were monitored throughout the procedure and were unchanged pre and postop status.Per op notes, the transverse processes at l5 as well as sacral ala were decorticated, local allograft supplemented with rhbmp-2/acs bone morphogenic protein soaked sponge wrapped around bone graft was impacted in the posterior region predominantly on the left side for the posterior fusion part of the procedure.Next, appropriate length rod was impacted over the screws, torquing the screws down to 80 inch pounds.Final radiographs were obtained, showed the hardware as well as anterior interbody grafts in excellent alignment.There was some softening of bone upon placement of screws, therefore at increased risk of pseudoarthrosis, failure of the hardware, but the patient placed in brace postop as well as follow up radiograph postoperatively.Patient underwent lumbar spine x-ray.Conclusion: no acute disease.On (b)(6) 2008: patient was discharged to home.On (b)(6) 2008: patient presented for post-operative follow up.Patient had difficulty urinating after the surgery.She also complained of a bruise on the left side of her neck.Patient also had a rash and petechiae in her abdominal area after wearing stockings.Assessment:major depression, single episode.Bulging disc (l5 - s1).Bulging intervertebral disc.Lumbar strain.Neck strain.Thoracic strain.On (b)(6) 2008: patient presented for post-op follow up.Lumbar spine x-ray showed satisfactory cage placement and satisfactory instrumentation.On (b)(6) 2009: patient presented for post-op follow up.On physical examination, patient had a narrow-based gait.Lumbar spine x-ray showed the hardware holding in good alignment at the l5-s1 level.Impression: painful recurrent disc protrusion at the l5-s1 level.On (b)(6) 2009: patient underwent physical therapies with primary diagnosis of bulging disc (l5 - s1); bulging intervertebral disc; lumbar strain; neck strain; thoracic strain.On (b)(6) 2009 the patient presented with complaints of low back pain due to work injury.On (b)(6) 2009: the patient presented with independent medical evaluation.On (b)(6) 2009 the patient present with complaints if mid and low back pain with occasional numbness and tingling in her arms and legs.She has cramping and radicular type pain down the right leg at times.Has difficulty in sleep.The physical examination reveals cervical spine has guarding in the paraspinal muscles with mild tenderness.Low back pain.On (b)(6) 2009: patient presented 6 months post-op surgery with back pain.Lumbar spine x-ray appeared satisfactory with good fusion and incorporation of cage and grafts.Instrumentation is unremarkable.On (b)(6) 2009: patient underwent chest x-ray.Impression: no active disease.(b)(6) 2009 the patient underwent x-ray of lumbar spine.On (b)(6) 2009 the patient came for an office visit with cramping in legs at night, difficulty with sleep, pressure, aching and burning sensation in the lower back.Physical examination reveal reduced rom for lumbar and cervical region.On (b)(6) 2009: patient presented 10 months post-op from laminectomy and fusion due to a painful recurrent disc protrusion at the l5-s1 level.Lumbar spine x-ray showed the hardware holding in alignment as well as good graft incorporation.Impression: painful recurrent disc protrusion, l5-s1.Patient also complained of back pain on (b)(6) 2010: patient underwent chest x-ray.Impression: no evidence of acute cardiopulmonary disease is seen.On (b)(6) 2011: patient underwent chest x-ray.Impression: negative study.No significant change since (b)(6) 2010.On (b)(6) 2011: patient presented with pain behind both knees.Cold and wet weather aggravated her symptoms.Assessment: major depression, single episode.Bulging disc (l5 - s1).Bulging intervertebral disc.Lumbar strain.Neck strain.Thoracic strain.On (b)(6) 2011, (b)(6) 2012: patient presented for follow up with improvement due to change in medication.Cold and wet weather aggravated her symptoms.She described her pain as being a constant achy and throbbing sensation.Assessment: bulging disc (l5 - s1).Lumbar radiculopathy.Neck strain.Major depression, single episode.On (b)(6) 2012: patient underwent chest x-ray due to positive ppd.Impression: no acute cardiopulmonary disease.No significant change since (b)(6) 2011.On (b)(6) 2012, (b)(6) 2013: the patient presented with complaints of constant episodes of severe bilateral lower back localized pain, radiating to the right buttock and right lower extremity.Patient described the pain as a "pressure" type feeling.Patient complained of constant pressure on the right side.Cold and wet weather aggravated symptoms along with prolonged activity.Assessment: extruded lumbosacral disc.Herniated disc (l5 - s1).Lumbar strain.Major depression, single episode.Neck strain.Thoracic strain.On (b)(6) 2012: patient presented with increasing achiness and back pain.Pain was described as frequent achiness and sharp right lower lumbar spine which goes from the buttock to the knee.Assessment: extruded lumbosacral disc.Herniated disc.On (b)(6) 2013: patient underwent mri lumbar spine with and without contrast.Impression: l5-s1: status post right laminectomy and int erbody and posterior fusion.Moderate epidural scarring about the right s1 nerve root which is mildly flattened and posteriorly displaced.No recurrent disc herniation.Small fluid collection about the right s1 nerve root, likely post surgical.On (b)(6) 2013: patient presented with low back pain.Impression: paiful recurrent disc protrusion l5-s1 now four years post-op from laminectomy and fusion with instrumentation at the l5-s1.On (b)(6) 2013: patient presented with low back and radicular symptoms.Clinical impression: recurrent lumbosacral right sacroiliac dysfunction with right lower extremity radicular paresthesias - uncertain etiology, status post lumbar spinal fusion at l5-s1four years postoperative.Chronic pain syndrome and narcotic dependency.Multiple medical problems.On (b)(6) 2013: patient presented for follow up with pain in the lower back going down the right leg.Assessment: extruded lumbosacral disc.Herniated disc (l5 - s1).Major depression, single episode.Thoracic strain.On (b)(6) 2013: patient presented with mid low back pain.Patient presented for evaluation with diagnoses of extruded lumbosacral disc, herniated disc, thoracic strain.Patient underwent therapeutic exercises.On (b)(6) 2013: the patient presented with back pain.On (b)(6) 2013: patient underwent chest x-ray.Impression: negative study and no significant change since (b)(6) 2012.On (b)(6) 2013: patient presented with back pain.Assessment: extruded lumbosacral disc.Herniated disc (l5 - s1).Lumbar strain.Major depression, single episode.Neck strain.Thoracic strain.On (b)(6) 2013: patient underwent electromyography and nerve conduction studies of the bilateral lower extremities.Assessment: lumbar or l/s radiculopathy; polyneuropahty in diabetes; low back pain; diabetes with neurological manifestation, type ii or unspecified type, not stated as uncontrolled.On (b)(6) 2013: patient presented with ongoing pain in the right lumbar spine especially the right.Patient has had physical therapy which made no difference in her symptoms.Patient complained of increasing pain going down the right leg and leg goes numb with prolonged sitting and driving.Patient complained of a constant throbbing and pressure in the mid to low back that goes down legs, pain and burning in the right buttock.Patient had fluid around the right s1 nerve root noted on the mri.Assessment: extruded lumbosacral disc.Herniated disc (l5 - s1).Lumbar strain.Major depression, single episode.Neck strain.Post-laminectomy syndrome (lumbar).Lumbar radiculopathy.On (b)(6) 2013: patient presented with a work injury, chronic history of back pain and radicular pain and recurrent symptoms.(b)(6) 2013: patient underwent ct myelogram lumbar spine due to back pain.Impression: surgical changes of l5-s1 posterior fusion and laminectomy.Soft tissue is seen along the right anterior aspect of the thecal sac at this level which corresponds to the scar seen on recent mr.The previously seen area of focal fluid near the right s1 nerve root is not appreciated on the current study.There is no focal csf collection, central canal stenosis or nerve root impingement identified.Patient also underwent lumbar myelogram.Impression: technically successful lumbar myelogram.On (b)(6) 2013: patient presented with some difficulty with recurrent symptoms.Emg was equivocal for any persistent radiculopathy.On (b)(6) 2013: patient presented with back pain.Patient stated that she had a ct guided myelogram and was having a burning sensation at the site of the contrast dye injection.In her low back patient, still had the constant feeling of pressure.Assessment: extruded lumbosacral disc.Herniated disc (l5 - s1).Lumbar strain.Major depression, single episode.Neck strain.Thoracic strain.On (b)(6) 2013: patient presented with back pain and abdominal pain after gallbladder surgery.Assessment: extruded lumbosacral disc.Herniated disc (l5 - s1).Lumbar strain.Major depression, single episode.Neck strain.Thoracic strain.On (b)(6) 2014 the patient presented with complaints of moderate, frequent pain in the low back with burning into both lower extremities, right greater than left.The patient reports that physical therapy aggravated her pain.Examination of the lower spine reveals 20 degrees flexion, 10 degrees extension and tender over the lumbosacral junction.Currently the patient allegedly cannot walk and cannot work.The patient's life activity were subjected to back pain as the result of the patient's 2003 injury.
 
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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 Key4382261
MDR Text Key19402562
Report Number1030489-2015-00018
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,Followup,Followup,Followup
Report Date 12/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Expiration Date08/01/2010
Device Catalogue Number7510400
Device Lot NumberM110704AAH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/09/2014
Initial Date FDA Received01/05/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received09/15/2015
10/26/2015
01/06/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/29/2008
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) Other;
Patient Age00040 YR
Patient Weight79
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