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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 7510400 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Pulmonary Embolism (1498); Cyst(s) (1800); Dyspnea (1816); Fatigue (1849); Headache (1880); Incontinence (1928); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Urinary Tract Infection (2120); Weakness (2145); Burning Sensation (2146); Tingling (2171); Stenosis (2263); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Dysuria (2684)
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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 using a posterior approach on the lumbar region from l5 to s1 using rhbmp-2/acs.Sometime postop, the patient reportedly began to experience pain, weakness, and numbness in her legs.On (b)(6) 2010, the patient underwent a revision to decompress her l5 and s1 nerve roots.The patient continues to report experiencing same symptoms, as well as bowel incontinence.
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Manufacturer Narrative
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(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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Manufacturer Narrative
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(b)(4).
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Event Description
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Per medical records it was reported that on: (b)(6) 1999 the patient was presented for office visit.Assessments: exogenous obesity, right radial nerve compression.On (b)(6) 2001 the patient was presented for office visit with migraines headaches.On (b)(6) 2001 the patient was presented for office visit with back pain.Assessments: left leg pain.Suspect radicular type pain.Pin worms.Migraines headaches.The patient underwent x rays of the back pain.Impressions: mild to moderate levoscoliosis in the lumbar spine, with mild to moderate disc space narrowing at l3-4 and l4-5, left lower facet degenerative changes, and right lower sacroiliac sclerosis.On (b)(6) 2002 the patient was presented for office visit.Assessments: normal examination, skin tags right lateral chest.Allergies, migraines headaches.On (b)(6) 2002 the patient was presented for office visit.Assessments: pulmonary embolism, headache, left ankle pain, left leg pain, history of pinworms.The also underwent ct scan of the head.No complication was reported.On (b)(6) 2002, (b)(6) 2003 the patient was presented for office visit for follow up pulmonary embolism.Assessments: follow up pulmonary embolism.On (b)(6) 2003 the patient was presented for office visit for follow up of bilateral lower extremity pain.On (b)(6) 2003 the patient was presented for office visit for follow up of her pulmonary embolism.Assessments: follow up pulmonary embolism.On (b)(6) 2003 the patient underwent ct scan of the chest.On (b)(6) 2003 the patient was presented for office visit with urinary frequency and dysuria.Assessments: urinary tract infection.On (b)(6) 2003 the patient was presented for office visit.She reported she felt cold much of the time.Assessments: hair loss, right temple lesion, 3) pulmonary function testing.On (b)(6) 2004 the patient was presented for office visit with tympanic membranes without erythema.Assessments: sinusitis/bronchitis.On (b)(6) 2004 the patient was presented for office visit for evaluation of the vaginal discharge.She had a mild amount of bilateral pelvic pressure.Assessments: vaginal discharge currently without significant symptoms.On (b)(6) 2004 the patient was presented for office visit with lower abdominal pain.On (b)(6) 2004 the patient was presented for office visit with bleeding complications.Assessments: left calf pain.On (b)(6) 2004 the patient was presented for office visit.Underwent left leg venogram.On (b)(6) 2004 the patient was presented for office visit with leg pain.Assessments: urinary tract infection.History of pulmonary embolism.On (b)(6) 2004 the patient was presented for office visit with back pain went away in the legs, but then there is this pain left over with numbness over the lateral part of her foot on the dorsal side and on the back of the leg.Assessments: possible some type of radiculopathy.The patient underwent xrays of the lumbosacral spine.On (b)(6) 2004 the patient was presented for office visit.Assessments: dyspnea.On (b)(6) 2004 the patient was presented for office with mild erythema in throat, sinusitis.Assessments: sinusitis/bronchitis.On (b)(6) 2005 the patient was presented for office visit.Assessments: low back pain.On (b)(6) 2005 the patient was presented for office visit with acute distress.The is mild edematous.Assessments: left foot and left third toe contusion.The patient underwent x rays of the left foot.Impressions: third toe contusion.(b)(6) 2005 the patient was presented for office visit with third toe contusion.Assessment: left third toe contusion, status post transfusion.On (b)(6) 2005 the patient was presented for office visit with chest pain.Assessments: headache and chest pain, right arm pain.On (b)(6) 2005 the patient was presented for her left chest wall pain.Assessments: chest pain.The patient also underwent x rays of the chest.No complication was reported.On (b)(6) 2006 the patient was presented for office visit.Impressions: cystitis, insomnia.(b)(6) 2006 the patient was presented for office visit for urinalysis.Assessments: presumed urinary tract infection with mild hemorrhagic cystitis.On (b)(6) 2006 the patient was presented for office visit with urinary problems.Assessments: hematuria with suprapubic pain and left flank tenderness and dysuria.On (b)(6) 2006 the patient was presented for office visit.Impressions: enlarged thyroid, fatigue, constipation.On (b)(6) 2006: assessments: low back pain, history of pulmonary embolism, history of asthma.On (b)(6) 2006 the patient was presented for office visit.Impressions: anxiety.On (b)(6) 2007 the patient was presented for office visit.Assessments: low back pain, fatigue, dysuria.On (b)(6) 2007 the patient was presented for office visit with low back pain.Assessments: lumbar l5-s1 disc herniation.On (b)(6) 2007, the patient was presented for office visit with low back condition.Assessments: low back pain.On (b)(6) 2007 the patient was presented for office visit with low back herniated disc.Assessments: low back pain with radiatio, fatigue.On (b)(6) 2007 the patient was presented for office visit with urinary frequency, burning.Assessments: urinary tract infection.On (b)(6) 2008 the patient was presented for office visit for ongoing urinary frequency, dysuria and urgency.On (b)(6) 2008: the patient was also presented for office visit with sinusitis.(b)(6) 2008 the patient was presented for office visit for dysuria symptom.Assessments: possibly urinary tract infection.On (b)(6) 2008 the patient was presented for office visit with urinary frequency, dysuria, spasms and urgency.Assessments: urinary tract infection.On (b)(6) 2009 the patient was presented for office visit with urinary frequency urgency dysuria.Assessments: cystitis.On (b)(6) 2009 the patient was presented for office visit for preoperative clearance for a spine surgery.On(b)(6) 2009 the patient was presented for office visit for evaluation of allergic reaction.On (b)(6) 2009 the patient was presented for office visit with tongue swelling and throat swelling.On (b)(6) 2009 the patient was presented for office visit with urinary symptoms.Assessments: dysuria, suprapubic tenderness, urgency, frequency.Symptoms sound compatible with a urinary tract infection.On (b)(6) 2010 the patient was presented for office visit for physical examination.Impressions: enlarged thyroid.Back pain.Facial rash.On (b)(6) 2010 the patient was presented for office visit for a preoperative history and physical examination.On (b)(6) 2010 the patient was presented for office visit with left anterior left thigh lesions 2) bulging discs at several levels.Assessments: left anterior thigh lesion.Low back pain.Possible cystocele.(b)(6) 2010 the patient was presented for office visit with urinary symptoms ¿tender bladder¿.(b)(6) 2011 the patient was presented for office visit with several skin lesions.Assessments: back pain, chronic, facial lesions.On (b)(6) 2011, the patient was presented for office visit with urinary symptoms.She complains of some dysuria, frequency, and some suprapubic tenderness.On (b)(6) 2013, the patient was also presented for office visit for medication refill.
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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) 2007: per the medical records.Left side extrusion of the nucleus pulposus at l5-s1 causing impingement of the traversing left s1 nerve root just above the level of the left lateral recess.There was a large extrusion causing impingement of the left s1 nerve root.On (b)(6) 2007: the patient underwent left sided l4-s1 discectomy, decompression of left l5 and left s1.On (b)(6) 2008: epidural steroid injection.On (b)(6) 2008: the patient underwent mri.Impression: disc desiccation at t11-12 and t12-l1 without bulging at that point.L5-s1 showed left hemilaminectomy or laminotomy with a disc protrusion such would represent postsurgical change.On (b)(6) 2008, and (b)(6) 2009: the patient underwent left s1 nerve root injection.On (b)(6) 2009: the patient went for an office visit to orthopaedics dept due to sacroilitis/ l5-s1.On (b)(6) 2009: the patient underwent couple of si joint injections for left buttock pain and low back.On (b)(6) 2009: the patient underwent five views of the lumbar spine which include flexion and extension lateral views.Impression: progressive degenerative disc disease l5-s1 status post work related left l5-s1 diskectomy, l5 sensory radiculopathy, moderately severe facet arthrosis l5-s1 associated with no.1.On (b)(6) 2009: the patient went for an office visit due to back pain.Impression: lumbar sprain with persistent left sciatica status post l5-s1 discectomy, left sacroilitis, persistent.On (b)(6) 2009: the patient underwent anterior lumbar interbody fusion at l5-s1 with posterior spinal laminotomy, hemilaminectomy, and foraminal decompression followed by posterior spinal instrumentation and fusion.Other implants that were used other than rhbmp-2/acs: spacer.Preop: l5-s1 degenerative disk disease with foraminal stenosis at l5-s1 on the left.Perop: a large size 10 x 8 degree anterior lumbar interbody spacer was filled with bone morphogenic protein and driven into place.Each of the pedicles were tapped and filled with appropriate sized 6.5 mm screws using 45 mm on the mid l and 40 in the sacrum.Gelfoam was placed over the dura.On (b)(6) 2009: the patient went for an office visit for follow up.On (b)(6) 2009: the patient underwent 3 views of the lumbar spine.Impression: good maintenance of all hardware position with good early osseous integration noted.On (b)(6) 2009, (b)(6) 2010: the patient presented with leg pain and deep burning across the low back.Assessment: painful retained hardware.On (b)(6) 2010: the patient underwent mri lumbar spine without and with contrast.Impression: t11-12 disc protrusion.L5-s1 interlim surgery with placement of fixation devices and clearing of previously apparent disc protrusion.
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Event Description
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It was reported that on (b)(6) 2010, the patient presented with constipation and nausea and underwent chest x-ray.Impression : no radiographic evidence of acute abdominopelvic process at this time.On (b)(6) 2011: the patient presented for occupational medicine consultation and disability assessment.On (b)(6) 2012, the patient presented for lumbar spine x ray: frontal and lateral radiographs.Impression :- accentuation of physiological lordosis.; horizontalisation of the sacrum.
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Manufacturer Narrative
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Event Description
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It was reported that on (b)(6) 2011 : patient presented for pathological examination.Diagnosis: left upper arm skin-basal cell carcinoma, superficial pattern, present at peripheral tissue.Right ulnar forearm-verrucous keratosis (b)(6) 2012: patient presented for procedure left upper arm.
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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: the patient presented with weakness, pain limiting range of motion.On (b)(6) 2006: the patient underwent three view lumbar spine examination.Finding: there is a very mild lumbar levoscoliosis.On (b)(6) 2006: the patient presented for recheck of her low back pain and underwent physical examination.On (b)(6) 2007: the patient presented for follow up visit.On (b)(6) 2007 (date unknown) patient presented with mri of the lumbar spine.On (b)(6) 2007: per the medical records and mri of the lumbosacral spine.On (b)(6) 2007: the patient presented with low back pain, going down left leg.On (b)(6) 2007: the patient presented for evaluation of her back and underwent mri.Impression: herniated disc at l5-s1 on the left, symptomatic.On (b)(6) 2007: the patient visit for consenting discussion regarding a left sided l5-s1 discectomy and underwent examination.Impression:herniated nucleus pulposus at l5-s1 level on the left.On (b)(6) 2007: the patient underwent single fluoroscopic spot performed intraoperatively.On (b)(6) 2007: the patient presented for recheck of her back.The patient underwent examination impression: herniated nucleus pulposus at l5-s1 level on the left status post discectomy.On (b)(6) 2007: the patient presented for recheck of her back.The patient underwent examination impression: status post l5-s1 discectomy.(b)(6) 2007: the patient presented for recheck of her back.The patient underwent examination impression: status post lumbosacral discectomy.On (b)(6) 2008: the patient presented for recheck of her back.The patient underwent examination.Impression: status post lumbosacral discectomy, continued lower back pain with occasional left sided radicular symptoms.On (b)(6) 2008: the patient presented for recheck of her back.The patient underwent examination.Impression: persistent low back pain and radiculopathy.On (b)(6) 2008: the patient returns to office visit for recheck of her back.Impression: status post lumbosacral discectomy, continues symptoms.On (b)(6) 2008: the patient returns to office visit for recheck of her back.Impression: status post lumbosacral discectomy, continues symptoms 2.Tight left hamstring.On (b)(6) 2008: the patient presented with post laminectomy for disc disease.The patient underwent physical examination.Impression: degenerative disc disease.On (b)(6) 2008: the patient presented with back pain and underwent injection procedure.On (b)(6) 2008, (b)(6) 2009: the patient presented for follow up with complaint of back pain and underwent examination.Impression: lumbar sprain with persistent left sciatica, status post left l5-s1 discectomy, left sacroilitis.On (b)(6) 2009: the patient presented for evaluation of her back pain.The patient presented with pain/burning and numbness.On (b)(6) 2009: the patient went for an office visit for followup of thyromegaly and hypothyroidism.On (b)(6) 2009: the patient presented for office visit for final consenting of her upcoming surgical procedure.The patient underwent ap and lateral view of the hip.Assessment: progressive degenerative disc disease l5-s1 status post work related left l5-s1 diskectomy, l5 sensory radiculopathy, moderately severe facet arthrosis l5-s1 associated with no.1.The patient presented with pain , tingling and numbness in left leg.On (b)(6) 2009: the patient went for an office visit for follow up with complaint of low back pain and sacroilitis.Patient underwent three views of the lumbar spine.Assessment: twelve days status post alif at l5-s1, followed by a posterior spinal laminectomy , hemilaminectomy and foraminal decompression on the left at l5-s1, followed by psif.On (b)(6) 2009: patient called to report her position.On (b)(6) 2009: patient underwent thyroid ultrasound.Impression: overall decrease in size of diffusely abnormal gland with appearance.No new or progressive abnormalities are seen.On (b)(6) 2009: the patient follow up for low back pain and underwent thoracic lumbar spine examination.Assessment: three months status post l5-s1 spinal fusion, improving.On (b)(6) 2009: the patient presented with complaint of low back and bilateral buttock/leg syndrome.Patient underwent thoracic/lumbar spine examination: assessment: four and a half months status post l5-s1 spinal fusion, slowly improving.On (b)(6) 2010: the patient presented for follow up with complaint of pain, burning, numbness and pain while walking.On (b)(6) 2010: patient presented with exam of thoracic/ lumbar spine.Assessment: 9 months status post l5-s1 fusion, with continued pain and left leg numbness.Painful retained hardware.On (b)(6) 2010: patient presented with an mri.Impressions: postoperative blood around the nerve root (normal).Patient was admitted to the hospital on (b)(6) 2010 and discharged on (b)(6) 2010.On (b)(6) 2010: the patient presented with preoperative diagnosis of left s1 radiculopathy with prominent hardware, possible pseudarthrosis.On (b)(6) 2010: patient presented with examination of thoracic/ lumbar spine.Assessment: one month status post posterior spinal l5- s1 decompression, l5 nerve root decompression, s1 nerve root decompression, with left sided foraminotomies, laminectomies, hardware removal and augmentation of fusion mass.On (b)(6) 2010: patient presented with examination of thoracic/ lumbar spine.Assessment: nine weeks status post lumbar surgery.Continued neurogenic pain of unknown etiology.On (b)(6) 2010: patient underwent an mri of the lumbar spine with and without contrast.Impressions: t11-12 disc protrusion, l5-s1 interim surgery with placement of fixation devices and clearing of previously apparent disc protrusion.On (b)(6) 2010: patient presented for an office visit due to low back and leg pain.On (b)(6) 2010: patient presented with low back, left leg pain and joint pain.Patient's oswestry test score indicated moderate functional impairment.Assessment: persistent back and left leg pain, spinal lumbar surgeries and hardware removal.The patient was diagnosed with following diagnosis : lumbar radiculopathy.Syndrome, postlaminectomy, lumbar.Degeneration, lumbar/ lumbosacral disc.Low back pain.On (b)(6) 2010: the patient went for an office visit with the following diagnosis: lumbar radiculopathy.Impressions: neurogenic pain status post decompression and fusion and resection of scar without improvement in pain.On (b)(6) 2010: patient presented with chief complaint of back and leg pain.Assessment: back and leg pain, lumbar surgeries, fusion and hardware removal.Persistent back and left leg pain.On (b)(6) 2010: patient presented with a chief complaint of low back and left leg pain.Patient also underwent a review of musculoskeletal systems which was positive for joint pain, low back pain, buttocks pain and weakness.A review of neuromuscular systems was positive for numbness.Assessment: back and leg pain, lumbar surgeries, fusion and hardware removal.Persistent back and left leg pain.On (b)(6) 2010: patient presented with low back and bilateral buttock pain.The patient was diagnosed with following diagnosis: lumbar radiculopathy, postlaminectomy syndrome, disc degeneration and low back pain.On (b)(6) 2011: patient was presented with a follow-up phone call.Assessment: back and leg pain due to spinal lumbar surgeries, fusion and hardware removal.Persistent back and left leg pain.On (b)(6) 2011: patient presented for a follow-up visit due to low back pain.Assessment: left s1 sensory radiculopathy, status post decompression.Narcotic addiction and disability associated with no.On (b)(6) 2011: patient presented with a follow-up visit.Patient underwent a review of musculoskeletal and neuromuscular systems which revealed: tenderness in left l-4/5 segment, l5/s1 segment, greater sciatic notch.Range of motion is moderately reduced.Pain with flexion and extension.Gait: ambulates with cane.Lower extremity exam reveals hypoesthesia in left l5 dermatome, s1 dermatome.On (b)(6) 2011: the patient presented for occupational medicine consultation.On (b)(6) 2011: patient presented with a follow-up visit with complaint of low back pain, bilateral buttock and left leg pain.On (b)(6) 2011: patient presented with a followup call.On (b)(6) 2011: patient presented with a follow-up visit with a chief complaint of low back pain, bilateral buttock, and leg pain.On (b)(6) 2011: patient presented with low back, leg pain, tingling and numbness.Patient also underwent review of systems which revealed: loss of range of motion, weakness and numbness.On (b)(6) 2011: patient presented with a follow-up visit with a chief complaint of low back pain, bilateral buttock, and leg pain.On (b)(6) 2011: patient presented with a follow-up call with complaint of pain.On (b)(6) 2012: patient presented with a follow-up visit with a chief complaint of low back pain.Assessment: chronic low back pain and persistent left leg pain, lumbar surgeries, fusion and hardware removal.On (b)(6) 2012: the patient presented with diagnoses of lumbar radiculopathy, syndrome postlaminectomy lumbar, degenerative lumbar/lumbosacral disc, low back pain.On (b)(6) 2013, patient presented for annual exam.On (b)(6) 2013, patient presented for follow-up on hypercholesteremia, mid back pain and vitamin b12 deficiency.Patient reported chronic constipation.On (b)(6) 2013, patient underwent mri of lumbar spine with and without contrast.Patient underwent mri of spine without contrast.On (b)(6) 2013, patient underwent colonoscopy.On (b)(6) 2013, patient presented for follow-up visit on dysuria, hypothyroidism and vitamin d and b-12 deficiency.On (b)(6) 2013, patient presented for follow-up visit on dysuria and vitamin b-12 deficiency.
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Manufacturer Narrative
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(b)(4).(disc herniation).
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Event Description
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It was reported that on, (b)(6) 2008: patient presented with left buttock pain with extension to her left leg and left calf after her lumbar surgery.On (b)(6) 2010: patient underwent mri scan of the lumbar spine.Impression: t11-12 disc protrusion.L5-s1 interim surgery with placement of fixation devices and clearing of previously disc protrusion.There is apparent multilevel spondylosis with disc bulges described segmentably.On (b)(6) 2010: the patient presented with diagnosis of back pain, constipation, history of cystocele, history of pulmonary embolus, hi story of asthma, degenerative joint disease.Patient presented with pelvic pain-unclear etiology.On (b)(6) 2013, patient underwent mri of lumbar spine with and without contrast.Patient underwent mri of spine without contrast.Impression: there are postoperative changes from fusion and posterior decompression at l5 s1, no bony narrowing of the canal or neuroforamen.There is some enhancing soft tissue that encroaches upon the left s1 root within the lateral recess and the left l5 root within the neuroforamen.This is probably epidural scar tissue from prior surgery; there is mild multilevel degenerative disease in the remainder of the lumbar spine.This includes a small inferiorly directed central disk extrusion at l2-3 causing mild to moderate canal stenosis without neuroforaminal narrowing.There is also mild canal narrowing at l3-4.On (b)(6) 2015, (b)(6) 2016: patient presented with chief complaint of chronic pain.
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