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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Catalog Number 7510200 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Conjunctivitis (1784); Cyst(s) (1800); Dysphagia/ Odynophagia (1815); Incontinence (1928); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Cramp(s) (2193); Hernia (2240); Stenosis (2263); Injury (2348); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Fibrosis (3167)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a spinal fusion surgery on the lumbar region of his spine from l3-l5 using rhbmp-2/acs.It was reported that the patient's post-operative period was marked by severe pain and numbness in his lower extremities, urinary incomitance, and chronic constipation.The patient felt a brief period of relief following his spinal surgery, he has since developed uncontrolled bone growth, severe pain and numbness that radiates from the lower back to the lumbar extremities, bladder incontinence, and chronic constipation.His chronic constipation requires routine digital disimpaction.His pain precludes him from driving, walking, standing, sitting, or lying down for any extending period of time.
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Manufacturer Narrative
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(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.
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Event Description
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It was reported that on (b)(6) 2007 the patient complained of 75% low back pain and 25% right leg pain.On (b)(6) 2007 the patient underwent radiological tests.Impression: mechanical low back pain and likely referred leg pain.On (b)(6) 2012 the patient presented with chief complaint of back pain.The patient's ct results were read.Impression: lumbar pain.On (b)(6) 2013 the patient presented with chief complaint of bilateral shoulder pain.The patient underwent mri tests.Impression: left shoulder partial rotator cuff tear, right shoulder partial rotator cuff tear.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2006, patient is tender in the right lumbosacrum of his back.Painful on tilting to the right on forward flexion.On (b)(6) 2006, patient complains of sleeping difficulty.The patient's lumbar spine active range of motion is within normal limits in all planes of movement and pain free, with the exception of 'stretching' sensation in his low back region.On (b)(6) 2006, patient presented for follow-up.Patient reported mild discomfort in his right lumbosacral area.On (b)(6) 2007, patient has had low back pain with right leg radiation.Pain is around the iliolumbar ligament on the right and also above the facet joints around the lumbosacral junction.Examination of the lumbar spine revealed decreased range of motion in all directions, with pain on extension and diffuse tenderness over the facet joints and right iliolumbar ligament.On (b)(6) 2008, patient underwent colonoscopy and esophagogastroduodenoscopy.Impression: lax gastro esophageal junction grade 1 erosion esophagitis possible short segment barett¿s esophagus, biopsied.On (b)(6) 2009, patient presented for office visit.Review of neurological examination: examination of the low back and normal lumbar flexion-extension.However, these movements cause right upper gluteal pain.On (b)(6) 2009 patient presented for follow-up.Patient¿s ct myelogram is reviewed and there is complete obstruction to the flow of contrast at l4-l5, and at l3-l4 there is moderately severe stenosis as well.On (b)(6) 2009 patient presented for visit.Patient has severe stenosis at l3-l4 with severe facet degeneration and extremely severe facet arthropathy with new bone formation in the spinal canal around the facet joint, causing occlusive stenosis at l4-l5.On (b)(6) 2009 patient presented for office visit.On (b)(6) 2009, patient presented for follow-up.On physical examination: patient is tender on the inside of his left leg and left buttock.On (b)(6) 2010: patient presented for follow up.Patient had a neurogenic bladder probably after some back surgery with large residuals.On (b)(6) 2010 : patient was discharged.On (b)(6) 2010 the patient underwent the physical therapy evaluate and treat.He states pain primarily in the low back/lumbar area as well as reporting some pain down into his posterior buttocks area.He states he has been having some issues with bowel and bladder.He states some constipation and also some bladder issues.He states that he feels that he has become overall deconditioned since surgeries and with his longer history of low back issues.On (b)(6) 2010: patient underwent an independent medical evaluation by a neurosurgeon.His findings are.¿patient¿s current complaints are difficulty with bowel control and he has accidentally defecated on occasion.He has stress incontinence in the sense that if he coughs or sneezes he will urinate into his clothing and urinates, he estimates, many times a day.Reflex patterns were normal in the upper and lower extremities except for his right ankle reflex which was hypoactive the current diagnoses are as follows: post traumatic radiculopathy secondary to auto accident.Stress incontinence of the bladder.Rectal hypoactivity with stool incontinence.Sexual hypoactivity secondary to lack of ability to have erections.On (b)(6) 2010: patient presented with chief complaint of chronic constipation.On (b)(6) 2010:patient complains of significant urinary frequency ,fecal urgency and incontinence."impression: the patient gives a classic history of lower motor neuron bowel and bladder dysfunction.¿ on (b)(6) 2010 :patient underwent cystoscopy and urodynamic evaluation.On (b)(6) 2010: patient presented for office visit.Impression: neurogenic bowel is the most likely diagnosis particularly in light of his tremendous urinary diagnoses.On (b)(6) 2010 patient presented for follow-up visit with complaint of chronic back pain.On (b)(6) 2010 the patient presented for electro diagnostic testing.Studies today did include right peroneal testing and he has normal conduction velocities along with well developed wave forms and good amplitudes.Additionally, his emg was carried out and he does have some minimal irritability in the 51 paraspinous region on the right, but the other paraspinous regions are normal and lower extremities are normal throughout.Therefore, at this point, there is minimal evidence of 51 irritability.He is still complaining of radicular type pain.On (b)(6) 2010 patient presented for follow-up visit with complaint of chronic back pain.On (b)(6) 2011: patient was evaluated during an occupational medicine consultation/complex case review.Chief complaint is low back pain, lower extremity dysesthesias, urinary and fecal incontinence, erectile dysfunction.The pain is diffuse and involves the thoracolumbar region and bilateral buttocks (right greater than left).The back pain is aggravated by prolonged walking, prolonged sitting, prolonged standing, prolonged lying, and cold weather.Occasional complaints of shoulder pain attributed to sleeping position.Assessment: persistent/recalcitrant subjective complaints of thoracolumbar pain, diffuse and generalized, with occasional radiation of pain/dysesthesias into the right lower extremity.On (b)(6) 2011 patient presented for follow-up visit regarding his ongoing chronic low back pain as well as his history of bowel and bladder incontinence.On (b)(6) 2011 patient presented for follow-up visit with the complaint of on going back pain which increased significantly in the past three weeks.On (b)(6) 2012 the patient presented with chief complaint of back pain for reviewing ct.Imaging: it appears as though the l3-4 area that i was questioning at his last ct scan from 2010 has shown increased sign of fusion.Impression: lumbar pain.On (b)(6) 2012 patient presented for follow-up visit with complaint of discomfort over the back.On (b)(6) 2009: patient¿s lumbar spine x-ray demonstrates moderate spondylosis and traction spurs but no spondylolisthesis.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2004, patient underwent biopsy of skin and removal of mole from his face.Assessments: nevus.On (b)(6) 2004, (b)(6)2005, (b)(6) 2006, (b)(6) 2010, patient presented for office visit.On (b)(6) 2005 the patient was presented for follow up.Assessments: elevated blood sugars and parasthesias at night.On (b)(6) 2005, patient underwent x-ray of chest.Patient underwent x-ray of neck.The patient was presented for office visit with numbness in both arms.On (b)(6) 2006 the patient was presented for office visit with irritation in his left eye.Assessments: conjunctivitis from the irritation.On (b)(6) 2006 the patient was presented for a dot physical.On (b)(6) 2006, patient had a mva and reported low back pain, lower extremity dysesthesias, urinary and fecal incontinence and erectile dysfunction.On (b)(6) 2006, patient presented for follow-up.Patient reported low back pain radiating down posterior buttock to just above knee.Patient underwent x-ray of lumbar spine which showed slight retrolisthesis of l2.No acute fractures and disc spaces are maintained.On (b)(6) 2006, patient presented for follow-up.Patient reported low back pain.Prolonged walking and standing increases pain.On (b)(6) 2006, patient presented for follow-up with low back pain.Physical examination: some mild discomfort in the right lumbosacral area, but it is very mild.Range of motion is completely normal without pain.Deep tendon reflexes 2+ and equal at knees and ankles.Straight leg raise negative sitting and supine.On (b)(6) 2006, patient presented for follow-up.Patient reported mild discomfort.On (b)(6) 2007, patient underwent mri of lumbar spine.Impression: diffuse degenerative changes.There is mild to moderate spinal stenosis at l3-4 with right greater than left lateral recess stenosis here.At l4-5 there are more prominent degenerative disc changes with rather marked spinal stenosis here and bilateral recess stenosis.In addition, below the disc level there is a fragment of disc material or osteophyte encroaching on the posterolateral thecal sac on the left measuring 5 x 10 mm.L3-4 and l4-5 look most significant.On 07/24/2007, patient presented for follow-up.Patient underwent x-ray of lumbar spine.Impression: 1.Mechanical low back pain secondary to mva.2.Possible neurogenic right leg pain.3.Facet arthrosis and spinal stenosis, preexisting.On 08/15/2007, patient presented for follow-up.Patient reported mechanical low back pain and right leg pain.On 09/12/2007, patient presented for follow-up.On 10/11/2007, 01/18/2008, patient presented for follow-up.On 01/18/2008 the patient was presented for office visit with hernia.Assessments: 1) ventral hernia.2) reflux, 3) colorectal cancer screening.On 02/04/2008, patient underwent colonoscopy and esophagogastroduodenoscopy.On 07/18/2008, patient presented for follow-up.On 08/12/2008, patient presented for follow-up.Patient reported back pain radiating down leg.Mri scan showed diffuse degenerative changes along with some moderate spinal stenosis at l3-4 with left lateral recess stenosis.L4-5 had disc changes and bilateral recess stenosis.There was a fragment of disc on osteophyte on left.On (b)(6) 2009, patient presented for follow-up.On (b)(6) 2009, patient presented for follow-up.On (b)(6) 2009, patient presented for follow-up.On (b)(6) 2010, patient underwent mri of lumbar spine.Impression: diffuse degenerative changes.There is mild to moderate spinal stenosis at l3-4 with right greater that left lateral recess stenosis here.At l4-5 there are more prominent degenerative disc changes with marked spinal stenosis here and bilateral recess stenosis.In addition below disc level there is a fragment of disc material or osteophyte encroaching on posterolateral thecal sac on left measuring 5 x 10mm.L3-4 and l4-5 look most significant.On (b)(6) 2010, patient underwent mri of lumbar spine with and without contrast.Impression: post-op changes of extensive posterior instrumented fusion with interbody spacer at l3-4 and l4-5 with resection of very large bulky synovial cyst.While neural canal remains mildly narrowed, there is improvement at all levels.Minor dural enhancement involving the anterior aspect of thecal sac at l5-s1.This may represent a small amount of dural fibrosis.2.There is persistently narrow neural canal centrally at l4-5.On (b)(6) 2011 <(>&<)> (b)(6) 2011, the patient presented for lab tests, fasting lipid profile was ordered.(b)(6) 2012, the patient presented for lab tests.And (b)(6) 2012, chronic worsening pain led to radiology examination.On (b)(6) 2012, (b)(6) 2013, (b)(6) 2014, the patient presented for follow-up due to chief complaint of low-back pain.Impression: chronic lower back pain in the setting of degenerative disc disease and facet arthropathy status post multiple surgical procedures culminating in an l3-l5 fusion.He has multilevel foraminal stenosis, most severe at l5-s1.Neurogenic bladder and bowel secondary to a nerve root injury erectile dysfunction secondary to a nerve root injury.Muscle spasm (b)(6) 2013 the patient presented with chief complaint of chronic low back pain.Impression.1chronic low back pain in the setting of multilevel degenerative disk disease and facet arthropathy satus post multiple surgical procedures culminating in l3-l5 fusion.2) multilevel foraminal stenosis most severe at l5 and s1.3) neurogenic bowel secondary to nerve root injury.On (b)(6) 2013, the patient presented for lab tests.On (b)(6) 2013 <(>&<)> (b)(6) 2013, the patient presented with diagnosis possible sleep apnea.On (b)(6) 2013, the patient presented for injection of a corticosteroid (medication used to relieve swelling and inflammation) into a joint (b)(6) 2013, the patient presented for lab collection.On (b)(6) 2014, the patient presented for diabetic teleretinal imaging.On (b)(6) 2014, patient presented for lab examination.On (b)(6) 2014, the patient presented for ecg.Impression: poor quality echo.Low-normal ejection fraction.Probably normal chamber size.No valvular disease noted.Dilated inferior vena cava suggesting volume overload.On (b)(6) 2014, the patient presented after having 4 beat run of vt.He was recommended imaging study.On (b)(6) 2014, the patient presented for injection in both shoulders for tendinitis.On (b)(6) 2014, the patient presented for follow up.On (b)(6) 2014, the patient presented for evaluation of stress echo report.On (b)(6) 2014 <(>&<)> (b)(6) 2014, the patient presented for medicine refill and follow-up.1on (b)(6) 2014, the patient presented for follow up due to abdominal pain.He reports constant aching low back and bilateral lower extremity pain.He attributes at least in part for lower extremity pain to evolving peripheral neuropathy.His back pain is at baseline.He reports flank pain and abdominal pain that is being worked up by the va.Constipation is a function of the opiates is a factor.He is continent of bowel and bladder.He reports fair amount of anxiety centering around his pain.Insomnia is a factor in related to his pain.On (b)(6) 2014, (b)(6) 2015 the patient presented with chief complaint of low back pain.On (b)(6) 2014, the patient presented for diabetic fundoscopic exam.On (b)(6) 2015, patient called requesting medicine refill.On (b)(6) 2015, the patient presented for increased left foot pain.Imaging study indicated early degenerative osteoarthritis in the first mp joint.Bony structures were intact and in anatomic alignment.Small calcaneal spur was present at the insertion of the plantar fascia.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2009 ,the patient underwent ct scan of lumbar spine.Impression: severe degenerative spinal canal stenosis at the l4/l5 level with near complete block of csf flow on the myelogram phase of the examination.Severe symmetric degenerative spinal canal stenosis at l3/l4 level.Severe degenerative spinal canal stenosis at the l5/s1 level with moderate to severe asymmetric right lateral recess stenosis.Moderate asymmetric bony right l5/s1 neuroforaminal stenosis.Mild to moderate degenerative spinal canal stenosis at the l2/l3 level.No spondylolisthesis on standing lateral neutral, flexion or extension phase of the examination.The patient underwent rad main sp lumbar min 4 view lumbar.Impression: possible subtle l4-l5 anterolisthesis with associated facet arthropathy.No abnormal motion.On (b)(6) 2009, the patient presented for an office visit due to back and bilateral leg pain and stenosis at l3-l4 and l4-5.On (b)(6) 2009, the patient presented with l3-l4 and l4-l5 stenosis.On (b)(6) 2009 ,the patient presented with preoperative diagnosis of l3-l4 and l4-l5 stenosis.The patient underwent the following procedure: l3-l4 and l4-l5 minimally invasive decompression.On (b)(6) 2009, the patient underwent rad main spine lumbar 1 view r1lumbar.On (b)(6) 2009, the patient presented for the follow up of his l3-l4 and l4-l5 minimally invasive decompression.The patient complained of back pain.On (b)(6) 2009, the patient underwent rad main abd comp w/pa chest r1abd, impression:1 nonobstructive bowel gas pattern.On (b)(6) 2009, the patient underwent inj/ant/ster/l or sac 1 lev c5 body.Impression uncomplicated ct guided l3/l4 epidural injection performed.On (b)(6) 2009, the patient presented for the follow up of his l3-l4 and l4-l5 minimally invasive decompression.Patient had low back pain.On (b)(6) 2010, the patient presented with following preoperative diagnosis l3-l4 and l4-l5 instability.The following procedure was preformed: l3-l4 and l4-l5 minimally invasive percutaneous fusion with percutaneous placement of allograft in a synthetic containment device with bone morphogenic protein-2 at l3-l4 and l4-l5 with bilateral pedicle screw fixation percutaneously at l3-l4 and l4-l5.Per op notes: after excellent removal of the disks at both levels confirmed as well as freely oozing abraded bony endplates and removal of cartilaginous endplates, a verifying balloon was placed at each level to confirm excellent discectomy and size the graft.Allograft was inserted in the synthetic containment device combined with small amount of bone morphogenic protein-2 at each level.Final a/p and lateral fluoroscopy demonstrated excellent position of these interbody grafts.Then pedicle were then tapped with cannulated tap.Final cap screw placed at each level with compression placed across the grafts by angling l3 and l5 bilaterally.14 jan 2010 the patient underwent of rad main spine lumbar.On (b)(6) 2010, the patient presented for follow up of l3-4 and l4-5 fusion.The patient underwent the x-rays of lumbar spine.Impression: interval posterior instrumentation from l3 through l5.On (b)(6) 2010, the patient underwent the physical therapy evaluate and treat.On (b)(6) 2010, the patient presented for follow up of l3-4 and l4-5 fusion.The patient complained of right lower buttock pain.The patient underwent x-rays of lumbar spine.Impression: stable postoperative appearance.Note the presence of a traditional segment at the thoracolumbar junction.On (b)(6) 2010, the patient underwent ct scan spinal body.Impression: uncomplicated right ct guided l5 hardware injection.The right l5 pedicle screw extends slightly into the right lateral recess.Fusion components are in the otherwise appropriate position without evidence of loosening or infection.Severe asymmetric bony stenosis of the right l5-s1 neuroforamen potentially jeopardizing the enhancing right l5 nerve root.Severe bony stenosis of the right s1 neuroforamen potentially jeopardizing the exiting right s1 nerve root.On (b)(6) 2010, the patient presented for an office visit due to severe right sided buttock an l distribution pain.On (b)(6) 2010, the patient presented with preoperative diagnosis: right s1 radiculopathy, right l5-s1 foraminal stenosis.The patient underwent the following procedure: right l5-s1 foraminotomy.On (b)(6) 2010, the patient underwent of rad main spine lumbar.On (b)(6) 2010, the patient presented for an office visit due to chronic low back pain.Patient complained of back and right leg pain.On (b)(6), the patient discharged with following diagnosis: low back pain, status post fusion l3-4, 3-5 with pedicle screws.The patient underwent following treatment: physical therapy evaluate and treat.On (b)(6) 2010, the patient presented for a check up.Impression: urinary incontinence, total, probably sphincter injury, does not appear to have overflow incontinence at the present time.On (b)(6) 2010, the presented for an office visit.Impression: likely a contractile bladder.Potential neurogenic bowel.Erectile dysfunction.On (b)(6) 2010, the patient presented with right buttock pain into his leg.Patient also complained of bowel function.On (b)(6) 2010, the presented for an office visit due to persistent pain in his right buttock and occasionally in his right leg.The patient underwent the ct scan of lumbar spine with and without contrast.Impression: interval instrumentation at l3-l4 and l4-l5.No osseous fusion across the disc levels.Resolution of osseous narrowing of the central spinal canal.There appeared to persistent foraminal narrowing.On (b)(6) 2010, the patient presented for electro diagnostic testing.On (b)(6) 2012, the patient presented for an office visit.Patient complained of muscle cramps and spasms in the right and left leg in the calves.On (b)(6) 2012, the patient underwent ct scan of lumbar spine.Impression: lumbar fusion and instrumentation from l3 to l5 with solid dorsal fusion and evidence for incorporation of the interbody grafts at l3-l4 and l4-l5.Bilateral foraminal compromise secondary to superior articular facet impingement at l3-l4, as well as evidence for mild canal stenosis at this level.Significant lateral recess compromise at l4-l5.High grade foraminal compromise on the right at l5-s1.Unilateral pars fracture is demonstrated on the left at the l5 level, but without associated listhesis.On (b)(6) 2012, the patient presented with chief complaint of back pain.On (b)(6) 2012, the patient presented for an office visit due to low back pain.Patient complained of high anxiety and moderately high depression.Impression: chronic low back pain in the setting of multilevel degenerative disk disease and facet arthropathy status post multiple surgical procedures culminating in l3-l5 fusion.Multilevel foraminal stenosis most severe at l5 and s1.Neurogenic bowel secondary to nerve root injury.Erectile dysfunction.History of umbilical hernia repair.On (b)(6) 2012, on (b)(6) 2013 the patient presented with chief complaint of chronic low back pain.Impression: chronic low back pain in the setting of multilevel degenerative disk disease and facet arthropathy status post multiple surgical procedures culminating in l3-l5 fusion.Multilevel foraminal stenosis most severe at l5 and s1.Neurogenic bowel secondary to nerve root injury.Muscle spasm.On (b)(6) 2013, the patient presented with chief complaint of chronic low back pain.Impression.Chronic low back pain in the setting of multilevel degenerative disk disease and facet arthropathy status post multiple surgical procedures culminating in l3-l5 fusion.Multilevel foraminal stenosis most severe at l5 and s1.Neurogenic bowel secondary to nerve root injury.As per plaintiff fact sheet currently the patient complains of extreme pain, gastrointestinal problems, radiculopathy, foraminal stenosis, bowel incontinence, bladder incontinence, nerve injury, erectile dysfunction, radiating leg pain and retrograde ejaculation, pain when rotating hip and extending legs, extreme difficulty/inability with sexual intercourse.In 2009-2010: the patient was diagnosed with spinal stenosis and lumbar pain.In (b)(6)2010: the patient was diagnosed with lumbar pan, bowel and bladder incontinence.In (b)(6) 2010: 2013: the patient was diagnosed with walking, lifting, bending rotating hip and extending legs.In (b)(6) 2012 - present: the patient was diagnosed with chronic lower back pain, urinary incontinence, muscle spasms, bowel incontinence, and erectile dysfunction.In 2011 - present: the patient was diagnosed with diabetes.In 2012: the patient was diagnosed with mental anguish/ depression.On (b)(6) 2009: the patient underwent l3-4 and l4-5 minimally invasive decompression use of intra-operative microscope in (b)(6) 2010: the patient was diagnosed with right l5-s1 foraminotomy.
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Event Description
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It was reported that on (b)(6) 2006, patient presented in er after injuring the thumb with a pocket knife.Patient underwent radiologic exam of left thumb due to knife injury which showed a knife blade embedded in the front, adjacent to the interphalangeal joint, apparently passing thorough the proximal phalanx.Impression: foreign body as noted.On (b)(6) 2009, patient presented for pre-op evaluation for lumbar surgery.On (b)(6) 2009 patient presented for office visit for pre-op evaluation for lumbar surgery.On (b)(6) 2010, patient presented for pre-op evaluation for lumbar spinal surgery.On (b)(6) 2010, patient presented for office visit for pre-op evaluation for lumbar surgery.On (b)(6) 2010, patient underwent procedure for l5-s1 foraminotomy for pre-op diagnosis of: right s1 radiculopathy, right l5-s1 foraminal stenosis.No complications were reported during the procedure.
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