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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 Dyspnea (1816); Neuropathy (1983); Pain (1994); Seroma (2069); Urinary Tract Infection (2120); Weakness (2145); Tingling (2171); Stenosis (2263); Urinary Frequency (2275); Anxiety (2328); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
Event Type  Injury  
Event Description
It was reported that in 2005, the patient developed the onset of low back pain and was diagnosed as having lumbar disk herniation.On (b)(6) 2005, reportedly, the patient underwent a percutaneous lumbar discectomy with resection of hematoma.On 13 feb 2006 the patient presented with back problems.Per the encounter notes the patient had fallen on their back on (b)(6) 2009 and had problems ever since.On (b)(6) 2006 the patient presented with l5-s1 spondylolisthesis with radiculopathy and underwent surgery that consisted of a l5-s1 laminectomy; l5-s1 trans-lumbar interbody fusion with infuse; peek anterior spacer traxis (abbot) device; l5-s1 pedicular fixation using pathfinder (zimmer) instruments; l5-s1 electromyogram-nerve conductive velocity studies, both lower extremities during pedicle screw insertion; 4 nerves tested , 2 levels.Per the operative report ¿¿ bone and infuse were placed into the space.The peek implant was then placed and pounded anteriorly so that it sat in the anterior 1/3 of the vertebral body and directly in the midline¿.¿ no patient complications were reported.On (b)(6) 2006 the patient was discharged from hospital.On (b)(6) 2007, reportedly, the patient underwent a revision surgery which consisted of removal of pathfinder screws.On (b)(6) 2008 the patient presented with chronic low back pain and chronic radicular pain, right > left and the diagnosis of post lumbar laminectomy syndrome the patient underwent surgery which consisted of a medtronic spinal cord stimulator insertion.Fluoroscopy was utilized in placement.An ekg was taken which revealed sinus rhythm with 1st degree a-v block otherwise normal.On (b)(6) 2008, the patient presented with low back pain and difficulty with stimulator.The patient underwent a fluoroscopic evaluation of spinal cord stimulator leads and spinal cord stimulator analysis and subsequent programming.No patient complications were reported.On (b)(6) 2008, reportedly, the patient presented with pain and underwent a ct scan.On (b)(6) 2009 the patient presented with constant pain and chronic radiculopathy.Medications: lorazepam and norco.On (b)(6) 2009, in a telephone encounter, the patient reported ¿pure, excruciating bone pain¿.It was reported that the patient was using the stimulator which was helping with the sciatica but not the back pain.The patient reported the lower back pain was progressive and had been going on for approx.6 weeks.On (b)(6) 2009, the patient presented with pain and underwent a lumbar spine x-rays were taken.Lumbar vertebral bodies demonstrated normal alignment and were without evidence of acute fracture or dislocation.There was mild diffuse spurring noted.The disc spaces demonstrated normal height.A neural stimulator was noted with leads extending superiorly off the level of the film submitted.Postop changes were noted at the ls-s1 disc.Status post cholecystectomy changes.On (b)(6) 2009, in a telephone encounter, the patient reported ¿bad bone pain¿ where sitting was almost impossible.On (b)(6) 2009, the patient presented in urgent care with right hand laceration (from broken glass) and past diagnosis of asthma, sp ondylolisthesis with chronic radiculopathy, and osteoarthritis.On (b)(6) 2009, in a telephone encounter, the patient was ordered hydrocodone-acetaminophen.On (b)(6) 2009 the patient presented with slow worsening chronic back pain.Diagnosis: lumbar disc degeneration.Medications: lorazepram and methadone.On (b)(6) 2009, in telephone encounter, the patient reported that they had cut back on the methadone as it was ¿a little strong¿ to take during the day.On (b)(6) 2009, in a telephone encounter, the patient reported that methadone was not working out as it made them ¿out of it¿.The dosage was lowered.On (b)(6) 2010, in a telephone encounter, the patient reported that the stimulator was no longer working on (b)(6) 2010, telephone encounter, the patient reported they had been told the leads for the stimulator were placed in the wrong coverage area.The patient wanted ¿everything taken out.¿ on (b)(6) 2010, the patient presented with lumbar spine back problems.The patient reported they had been feeling ¿terrible¿, was having neck pain and loss of feeling in the left fingers.The patient reported their nerve stimulator was not working and pain had increased including the area in which they had had surgery.Medications: methadone and lorazepram.Diagnosis: lumbosacral neuritis and lumbar disc degeneration.The patient wanted the stimulator removed.On (b)(6) 2010, the patient presented with painful dorsal column stimulator (dcs) and underwent surgery which consisted of removal of the dcs battery pack and leads.No patient complications were noted.On (b)(6) 2010, the patient presented for a surgical f/u on the removal of the dcs.The patient reported that 1/3 of the pain had been relieved.Pocket pain improved but neck and low back pain persisted.The patient reported neck pain with bilateral hand numbness and back and right leg pain.Assessment: cervical stenosis and lumbar radiculopathy.The patient underwent a mri of both the cervical spine (which showed clear root compression) and lumbar spine (which showed l4-5 moderate stenosis) and a creatinine lab.Creatinine was normal.On (b)(6) 2010, the patient presented with neck pain and left hand numbness (onset trauma 4 mo prior).The patient underwent a mri of the cervical spine which demonstrated minimal disc bulging at c3-c4 and minimal disc spur protrusion at c2-c3 and c4-c5 without significant disc herniation or neural foraminal compromise.A lumbar spine mri showed post-surgical changes, ls-s1 with no abnormal mass effect upon the thecal sac.Degenerative disc bulging with encroachment upon the left neural foramen at l2-l3 and l3-l4.The l3 nerve root on the left was posteriorly displaced.There was moderate overall canal stenosis at l4-l5 related to disc bulge, ventral ridging and facet degenerative change with mild to moderate bilateral neural foraminal narrowing.Presumed post-surgical seroma within the subcutaneous fat centered overl3 as above.There was a peripheral enhancement which would not be unexpected given the recent surgery.An abscess could have a similar appearance if there were concern for infection.On (b)(6) 2010, the patient presented with pain and a decompressive laminectomy l4-5 procedure was discussed.Labs were ordered.On (b)(6) 2010, in a telephone encounter, the patient reported increased pain.The patient mentioned they were scheduled for a lam inectomy and wanted a rx for a home hospital bed.On (b)(6) 2010, the patient presented with l4-l5 stenosis and underwent surgery which consisted of a l4-5 laminectomy.No patient complications were noted.On (b)(6) 2010, in a telephone encounter, it was reported that the patient had fallen on their back the night before and there was some bruising around incision.On (b)(6) 2010, the patient presented for a post op f/u with lessening back pain but some nerve discomfort in back.Medications: methadone and meperitab.On (b)(6) 2010, the patient presented with some back swelling and improved pain.Medications: oxycodone-acetaminophen and lorazepram.On (b)(6) 2010, in a telephone encounter, the patient reported that the percocet was making them sick and wanted to be switched back to methadone.Methadone was prescribed and percocet discontinued.On (b)(6) 2010, the patient presented with back pain and weakness in legs which were reported as to have worsened in the past few weeks.The patient reported at least 50 falls over the prior two weeks.The patient reported that the methadone did not seem to be helping any longer.Assessment: recurrent stenosis or herniated nucleus pulposus (hnp).On (b)(6) 2010, in a telephone encounter, a scooter was ordered for mobility.On (b)(6) 2010, the patient presented with pain and underwent a lumbar spine mri which demonstrated interval spinal decompression with bilateral laminectomy changes at l4-ls; stable postsurgical changes ls-s1; stable moderate neural foramina narrowing left l4-l5 and mild on the right; and resolution of the presumed posterior subcutaneous seroma.On (b)(6) 2010, in a telephone encounter, the patient reported that the methadone had ¿changed her personality.¿ on (b)(6) 2010 the patient presented with chronic pain and depression with suicidal ideation secondary to pain.Medications: methadone, benzodiazepine, trazadone, and citalopram.On (b)(6) 2010, the patient presented with neck and low back pain related to prior surgeries.It was reported that the patient had a lot of instability with gait even while using a cane.The patient had a lot of difficulty with pain control, insomnia, and anxiety.On (b)(6) 2010, the patient presented with back and neck pain the patient reported constant, sharp and stabbing low back pain that radiated into the buttocks/iliac crest regions bilaterally which interfered with activities of daily living.The patient was being treated with methadone which was reported as helping the pain but causing significant fatigue and mood swings.Medications: abilify, estradiol, advair, lorazepam, trazadone, spiriva, celebrex, and methadone.On (b)(6) 2010, the patient presented with congestion, drainage, and copd.On (b)(6) 2010 and (b)(6) 2010, the patient reported that their pain was partially controlled wit hmethadone but that they felt it caused significant mood swings.The patient reported significant depression without suicidal ideation secondary to pain and dysfunction.On (b)(6) 2010, in a telephone encounter, the patient reported sleep difficulty.On 22 oct 2010 the patent reported the inability to sleep.On (b)(6) 2010 and (b)(6) 2010 the patient presented with opioid dependence, low back and bilateral leg pain with intermittent falling due to right leg weakness.Medications: embeda, msir, terazodone, and zofran.On (b)(6) 2010, in a telephone encounter, the patient reported msir dosage was not enough for breakthrough pain.On (b)(6) 2010, in a telephone encounter, the patient reported they had a uti and ¿dribbling¿, increased urgency, and fouls smelling urine (onset three weeks prior).On (b)(6) 2010, in a telephone encounter, the patient reported embeda and msir were causing nausea.On (b)(6) 2011, in a telephone encounter, the patient reported vicodin was not controlling the pain.On (b)(6) 2011, the patient presented with improved pain.The patient reported that since the introduction of morphine (msir) to their regime the pain had improved.The patient had low back and bilateral leg pain with intermittent falling due to right leg weakness.The patient ambulated slowly with use of a cane.Medications: opana.On (b)(6) 2011 and (b)(6) 2011 the patient presented with low back and bilateral leg pain.On (b)(6) 2011, in a telephone encounter, the patient reported that they believed the opana was causing shortness of breath.On (b)(6) 2011, the patient presented with a history of tinea versicolor.The patient also reported anxiety, insomnia and chronic pain.On (b)(6) 2011, in a telephone encounter, the patient reported increased shortness of breath and difficulty breathing (onset 2 days prior).On (b)(6) 2011 the patient presented with concerns on medication for pain and depression.On (b)(6) 2011 the patient presented with improved back pain, bilateral leg pain, opioid dependence and falling.On (b)(6) 2011 the patient presented with unchanging blurry vision in the right area with pressure and chronic pain due to degenerative disc disease and spinal stenosis.On (b)(6) 2011, in a telephone encounter, the patient reported they were doing well on opana and only had sciatica pain.On (b)(6) 2011, in a telephone encounter, the patient called to discuss ringworm on their chest.On (b)(6) 2011, in a telephone encounter, the patient reported heart palpitations, shortness of breath, and nausea.The patient was being treated for bronchitis but reported the feelings they were having felt different than bronchitis.It was advised that the patient go into the er.On (b)(6) 2011 the patient presented with low back pain, bilateral leg pain, opioid dependence, and intermittent failing.The patient reported mild dyspnea and the desire to wean off of medications.On (b)(6) 2011 the patient presented with the assessment of low back pain, tobacco abuse, copd and depression.It was reported that the patient had successfully weaned off of most of the pain medications.It was also reported that the patient was sleeping better and had almost no back pain.On (b)(6) 2011 the patient presented with acute onset bronchitis with associated symptoms.A chest x-ray was taken which showed minimal left basilar atelectasis, scarring or fibrosis; nonspecific increased interstitial markings bilaterally, most likely related to patient's history of smoking; and no acute focal consolidation or congestive heart failure.On (b)(6) 2011 the patient presented with cold like symptoms.Impression: pharyngitis.A throat culture showed no strep.On 10 nov 2011, in a telephone encounter, the patient reported their cold had gotten worse and they felt they had an infection and that it had gone into their lungs.The patient was prescribed a z-pak.On (b)(6) 2012, in a telephone encounter it was reported that the patient had gone in to a facility for a left knee injury ¿ possible meniscus tear.On (b)(6) 2012 the patient presented with cough, nasal drip, and fatigue.Diagnosis: gerd and sinusitis.On (b)(6) 2012, the patient presented with fatigue, left knee pain and osteoporosis.On (b)(6) 2012 the patient was reported to have hypothyroidism.On (b)(6) 2012 the patient presented with urinary frequency and urgency and for a thyroid check.Labs revealed elevated tsh (thyroid stimulating hormone).White blood cells were present in the urinalysis.Urine culture was positive for klebsiella pneumoniae.On (b)(6) 2012, the patient presented with hot flashes palpitations, dyspnea, shortness of breath and increased panic attacks.Diagnosis: emphysema, gerd, and hypothyroidism.Labs revealed low mpv levels and elevated tsh.On (b)(6) 2012 the patient presented with cough and was prescribed z-pak.On (b)(6) 2013, the patient presented with stomach bloating with nausea, some constipation, acid reflux, and back pain and possible thyroid issues.Labs were taken which were unremarkable.On (b)(6) 2013, the patient presented with right lower quadrant pain, nausea and vomiting.The patient underwent an abdominal/pelvic ct which revealed no findings that would explain the patients¿ pain.It should be noted that images through the lung bases revealed mild dependent atelectasis and coronary calcifications.On (b)(6) 2013, the patient presented with recurrent back pain and right sciatica pain.It was suspected that the patient had a new disk herniation at l4-5, right above the lumbar fusion of l5-s1.On (b)(6) 2013, in a telephone encounter, it was reported that a mri showed narrowing of the nerve holes and arthritis on both sides of the spine above the fusion.On (b)(6) 2013, the patient presented with leg numbness, leg pain, low back pain, and radiculopathy.The patient underwent an epidural steroid injection.On (b)(6) 2013, in a telephone encounter, the patient reported approx.30% reduction in pain after first epidural steroid injection (esi).On (b)(6) 2013, the patient presented with leg numbness, leg pain, low back pain, and radiculopathy.Diagnosis: l4-l5 stenosis, facet arthropathy, low back pain and sciatica.The patient underwent an epidural steroid injection.No patient complications were noted.On (b)(6) 2013, the patient presented in urgent care with lower lobe pneumonia and prescribed doxycycline.On (b)(6) 2013, it was reported that the patient was sick to their stomach from the doxycycline prescribed on the 16th.The patient was prescribed levaquin instead.On (b)(6) 2013, patient presented with osteoarthritis of the neck and shoulder and knee pain.The patient reported that they got ¿locked up¿ in the afternoon.The patient problems list was as follows: constipation, degeneration of the cervical intervertebral disc; degeneration of the lumbar disc; emphysema; fatigue; gerd; hypothyroidism; major depressive disorder, scoliosis and kyphoscoliosis, spinal stenosis of the lumbar region, and urinary frequency.Diagnosis: polyarthralgia.On (b)(6) 2013, in a telephone encounter, the patient reported an increase in pain as they were titrating down on prednisone.On (b)(6) 2013, in a telephone encounter, the patient reported tingling in legs and arms, pain everywhere and heart palpitations.The patient wanted to be referred to a cardiologist.The patient also reported lots of shoulder, neck, hip and thigh pain.On (b)(6) 2013, in a telephone encounter the patient reported concerns of possible cardiac problems.The patient reported tingling all over and heart palpitation possible secondary to anxiety.
 
Manufacturer Narrative
(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
 
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Brand Name
INFUSE BONE GRAFT
Type of Device
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key4204481
MDR Text Key4978078
Report Number1030489-2014-04145
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
Type of Report Initial
Report Date 09/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7510400
Device Lot NumberM115009AAI
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/29/2014
Initial Date FDA Received10/27/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/24/2006
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 Weight57
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