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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number 7510800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Ossification (1428); Fatigue (1849); Headache (1880); Incontinence (1928); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Weakness (2145); Tingling (2171); Stenosis (2263); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Depression (2361); Numbness (2415); Ambulation Difficulties (2544)
Event Type  Injury  
Event Description
It was reported sional that the patient underwent a posterolateral and anterior lumbar interbody fusion procedure from l4 to s1 using rhbmp-2/acs on (b)(6) 2008.The rhbmp-2 and collaged sponge was placed in the disc space and posterolateral gutters.The patient's post-operative period was reportedly marked by initial relief followed by increasing pain and weakness in the lower back and extremities.The patient underwent multiple aspirations in 2009 to resolve inflammatory fluid collections, as well as revision surgeries on (b)(6) 2009 and (b)(6) 2013 to remove bone overgrowth from the surgical site.On (b)(6) 2014 a lumbar ct myelogram showed bony overgrowth again on the patient¿s spine and exiting nerve roots.The patient also reports bowel and bladder incontinence, numbness and loss of sensation in his groin and cannot sit or stand for long periods of time.The patient uses a wheelchair for mobility.
 
Manufacturer Narrative
(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.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on: (b)(6) 2008: pre-op diagnosis: degenerative lumbar disease, l4 to s1.Severe lower back pain.Post laminectomy syndrome status post two previous back surgeries, l4 to s1.Bilateral leg radiculopathy, left greater than right.Bilateral sacroiliitis.Spondylosis, l4 to s1.Procedure: posterior spinal fusion from l4 to s1.Posterior spinal instrumentation, l4 to s1.Anterior diskectomy via left posterolateral approach at l5-s1.Anterior inter body fusion at l5-s1 with carbon fiber cage, bmp/allograft bone/auto graft bone.Left hemi laminectomy revision, l5-s1.Left l5 far lateral nerve root decompression/revision.Bilateral facetectomies at l5-s1 and l4-l5.Bilateral sacroiliac injections.Intraoperative fluoroscopy with interpretation.X-rays with interpretation, 'ls' spine 2 sets.Revision of posterior surgical scar approximately 10cm.Auto graft harvest from bilateral iliac crest from stem cell concentrate.Allograft bone/30ml/ morcellized.Per-op notes: dissection was carried down left and right spinous process.Patient had extensive amount of oozing throughout the tissue.Surgeon proceeded to dissect down on both side of spinous process exposing the lamina and t hen the facet joints at l4-l5 and l5-s1.Patient had extensive amount of scar tissue particularly on the left side at l4-l5 and l5-s1 level.Patient had degenerative changes at l5-s1 level, surgeon harvested the bone marrow stem cells then surgeon proceeded with pedicle screw fixation.Surgeon did bilateral facetectomies at l4-l5 and l5-s1 levels before placing the screws.Surgeon then proceeded to tap the hole and then placed the screws.Then surgeon proceeded to do hemi laminectomy on the left side.The bone was morcellized.Surgeon then proceeded to do a far lateral nerve root decompression pf the left l5 nerve root.The disk was then exposed at this level, disc was incised and removed.Bmp with bone graft along the anterior lip of the l5-s1 level was passed followed by the cage.Additional allograft bone and auto graft bone was packed posterior to the cage.The cage was filled with bmp.Rods were placed bilaterally from l4 to s1.The bone graft and bmp was packed along the posterolateral gutters from l4 down to the sacrum.Surgeon placed allograft bone as well as auto graft bone, which was utilized along the posterolateral and posterior elements.A cross link was applied between l5-s1 screws from left to right.Patient under went spine lumbar x-table lateral.It shows disk space narrowing at l5- s1.Vertebral bodies appear normal in height and alignment.Patient also under went portable anteroposterior and lateral lumbar spine.Impression: status post posterior spinal fusion, l4 to s1.Patient also under went anteroposterior spine portable chest view.Imp ression: low volume lungs with patchy bibasilar atelectatic change.Right neck central line and endotracheal tube in place.On (b)(6) 2008: patient under went anteroposterior erect portable chest view.Impression: endotracheal tube and right neck central line remain in place.On (b)(6) 2008: patient presented for follow of her l4 down to the sacrum fusion.Assessment: status post l4-s1 secondary to the spondylosis/post laminectomy syndrome.Severe low back pain, improving.Bilateral leg radiculopathy, improving.Persistent patchy bibasilar atelectatic change.On (b)(6) 2008: patient presented for follow of her l4 down to the sacrum fusion.Assessment: lower back pain, improving.Bilateral leg radiculopathy, improving.Patient under went x-ray, anteroposterior and lateral of the lumbar spine which are consistent with l4 down to the sacrum fusion.Screws and rod appear to be well situated.On (b)(6) 2008: patient presented for follow up of his posterior spinal fusion, l4 down to the sacrum doing well.Patient has right thigh pain and back discomfort.Assessment: spondylosis l4-s1.Post laminectomy syndrome.Severe low back pain/ bilateral sacroiliitis.Bilateral leg radiculopathy.On (b)(6) 2008: patient presented for follow up of his back surgery l4 to sacrum fusion.The pain has come back and patient had a left leg radiculopathy with some numbness and tingling all the way down to the left first metatarsal.Assessment: spondylosis l4-s1.Post laminectomy syndrome.Severe low back pain/ bilateral sacroiliitis.Bilateral leg radiculopathy.Patient under went x-ray, anteroposterior and lateral of the lumbar spine which shows the fusion is healing well.Nice overall lordosis.On (b)(6) 2008: patient under went mri lumbar spine without contrast.Impression: prior pedicle and rod fixation artifactual limitation, determination from lower l3 through l5-s1 limited.On (b)(6) 2008: patient under went ct lumbar spine with contrast.Impression: postoperative changes are present at l4, l5 and s1.No de finite stenosis at l4-5 or l5-s1 disc spaces.Mild stenosis at l3-4, due to some bulging of disc annulus, as well as ligamentum flavum hypertrophy and hypertrophic changes in the facets.There are schmorl's nodes at l3-4, l2-3, and l1-2.Patient also under went my elogram lumbar.Impression: mild stenosis at l3-4 with very slight thinning of nerve roots more prominent on the left.Patient has schmorl's nodes.On (b)(6) 2009: patient presented for follow up of his left leg radiculopathy.Patient continues to be very symptomatic with left leg pain.Assessment: spondylosis l4-s1, status post posterior spinal fusion with instrumentation.Post laminectomy syndrome.Left leg radiculopathy.Left sacroiliitis.Patient under went ct myelogram, which shows fusion/instrumentation from l4-s1.Patient appears to have some foraminal stenosis, possible bone growth/possible scar tissue at l5-s1 level, mostly on left side.On (b)(6) 2009: patient presented for preoperative workup for his surgery.Patient under went x-ray of chest.Impression: no acute changes are detected.On (b)(6) 2009: pre-op diagnosis: degenerative lumbar disease, l4 to s1.Status post previous posterior spinal fusion with instrumentation, l4 to s1.Bilateral leg radiculopathy, left greater than right.Formal stenosis, l4 and l5 nerve roots.Bilateral sacroiliitis.Procedure: removal of hardware, crosslinks, cap screws and rods from l4 to s1.Re-instrumentation with hardware from l4 to s1.Exploration of fusion from l4 to s1.Posterior spinal fusion from l4 to s1.Left hemi laminectomy l5 to s1, revision and l4-l5.Left l5 and l4 far lateral nerve root decompression revision.Right hemi laminectomy l5-s1.Right l5 far lateral nerve root decompression, revision.Right hemi laminectomy, l4-l5.Right l4 far lateral nerve root decompression.Bilateral sacroiliac injections.Auto graft harvest from posterior spinal elements morcellized.Microscope.Fluoroscopy with interpretation, x-ray with interpretation, "ls" spine series.Revision of surgical scar.Epidural steroid injection left l5, l4 nerve root and right l4, l5 nerve root.Review of system: significant for headaches, joint stiffness, joint pain, frequent urination and fatigue.Patient under went x-ray of lumbar spine, frontal and lateral view of lumbar spine.Impression: status post posterior spinal fusion, l4 to s1.Patient under went ct myelogram, which showed fusion from l4 to s1.Assessment: spondylosis, l4 to s1 status post fusion, l4 to s1 with instrumentation.Post laminectomy syndrome.Bilateral leg radiculopathy, left greater than right.Foraminal stenosis, secondary to bone over growth, l4 and l5 nerve roots.Patient's assessment by the physician: borderline hypertension.Elevated bleeding tendencies.Environmental allergies.On (b)(6) 2009: patient presented for post surgery follow up with minimal numbness, tingling and back pain.Assessment: spondylosis l4-s1, status post posterior spinal fusion with instrumentation.Post laminectomy syndrome, resolving.Left leg radiculopathy, resolving.Left sacroiliitis, resolving.On (b)(6) 2009: patient presented for follow up of his lower back/fluid collection.Assessment: status post l4-s1 revision of posterior spinal fusion with instrumentation, secondary multi level spondylosis.Post laminectomy syndrome.Left leg radiculopathy, improving.Lumbar wound fluid collection.On (b)(6) 2009: patient presented for follow up of his lumbar wound.Patient continues to have fluid collection down in lumbar wound.Patient has pressure throughout the back and on occasions gets the pain down into the leg.Assessment: status post l4-s1 revision of posterior spinal fusion with instrumentation.Post laminectomy syndrome.Lumbar wound.Deep muscular dehiscence with fluid collection.On (b)(6) 2009: patient presented for office visit.On (b)(6) 2009: pre-op diagnosis: lumbar wound dehiscence.Lower back pain.Bilateral sacroiliitis.Status post previous posterior spinal fusion l4 to s1.Procedure: "i & d" of lumbar spine with re-closure of wound.Bilateral sacroiliac injections.Exploration of fusion l4 to s1.Lumbar wound re closure.Revision of previous surgical scar.X-ray with interpretation ls spine series.Deep wound cultures aerobic, anaerobic, tb and fungus.Patient under went x-ray of lumbar spine.Impression: post surgical changes within the soft tissues lower lumbar spine.Posterior fusion l4-l1.Review of system: significant for headaches, joint stiffness, joint pain, frequent urination and fatigue.On (b)(6) 2009: patient presented for follow up of drainage, fluid collection, from the lumbar surgical site.Assessment: status post deep muscular wound closure.Status post l4-s1 revision of posterior spinal fusion with instrumentation.Post laminectomy syndrome.Lumbar wound.On (b)(6) 2011: patient presented for office visit with high blood pressure.Review of systems: musculoskeletal: lumbar skin shows a 5 inch long lumbar laminectomy scar.On (b)(6) 2011: patient presented for office visit.On (b)(6) 2012: patient presented for office visit with running nose.On (b)(6) 2012: patient presented for follow up visit.On (b)(6) 2012: patient presented for office visit for evaluation of his left leg radiculopathy status post revision l4 to sacrum fusion with instrumentation.Patient has sporadic pain at left leg with some weakness on the dorsiflexion and back pain.Assessment: history of l4 to sacrum fusion with instrumentation.Post laminectomy syndrome.Left leg radiculopathy.Transition changes.Patient under went x-ray anteroposterior and lateral of lumbosacral spine, which is consistent with fusion from l4 to sacrum.Screw and rods appear well situated.Bone graft appears to be incorporating well.Patient has minimal degenerative changes above at l3-l4 level.On (b)(6) 2012: patient presented for office visit.On (b)(6) 2012: patient presented for office visit.On (b)(6) 2013: patient presented with low back pain radiating into left leg.Patient under went myelogram injection procedure lumbar myelogram.Impression: there is a complete block at l3-4 and no contrast is seen extending into the lower lumbar and sacral portions of the spine.Pedicle screws are in good position.Patient under went ct lumbar spine with contrast.Impression: there is a total block beginning at bottom of l3 and extending through sacral portion of the spine.No contrast is seen entering the lower dural sac after myelogram.On (b)(6) 2013: patient presented for follow up with continuous numbness and weakness throughout both legs and lack of sensation throughout gluteal region down the legs as well as loss sensation during intimacy.Patient also has back pain.Assessment: history of previous fusion with instrumentation l4 to the sacrum.Severe spinal stenosis with complete block on ct myelogram at l3-l4 level.Severe spinal stenosis at l3 to l5 with moderate stenosis l2-l3.Spinal stenosis of lumbar region.Bilateral leg numbness/ weakness of gait.Numbness of lower limb.Failed non operative treatment.Patient under went ct myelogram of the lumbosacral spine, which is consistent with the fusion from l4 down to the sacrum.Patient has a complete block at l3-l4 level.Patient also has facet arthrosis at l3-l4 and l2-l3.Patient presented for follow up with back pain.Patient also under went x-ray of chest 2 views.Impression: no acute changes are detected.On (b)(6) 2013: patient presented for office visit with low back pain.On (b)(6) 2013: patient presented for pre surgery office visit.Assessment: severe spinal stenosis l3 to s1 with associated bilateral radiculopathy.On (b)(6) 2013: pre-op diagnosis: severe spinal stenosis from l1-s1.Bilateral leg radiculopathy.Bilateral sacroiliitis.History previous fusion with instrumentation, l3-s1.Post-op diagnosis: severe spinal stenosis from l1-s1.Bilateral leg radiculopathy.Bilateral sacroiliitis.History previous fusion with instrumentation, l3-s1.Intraoperative durotomy.Procedure: lumbar laminectomy, l1-s1 with primary repair of intraoperative durotomy.Bilateral sacroiliac injection.Microscope.Epidural steroid injection, l1-s1 bilaterally.Revision of previous surgical scar.Intraoperative fluoroscopy with interpretation.Exploration of previous fusion.Removal of hardware/crosslink.Review of systems: patient complains of headache, joint stiffness, low extremity numbness, frequent urination, joint pain, fatigue.Patient under went ct myelogram of lumbosacral spine, it is consistent with the previous fusion from l4-s1.Patient has severe block at l3-4 with no evidence of any contrast across this level.Pronounced facet arthrosis l4-5, s1 causing some central stenosis and also possibly some foraminal stenosis.Mild stenosis at l2-3.Assessment: history of previous fusion with instrumentation l4-s1.Severe spinal stenosis, extending from l3 down to the sacrum with a complete block on ct myelogram at l3-4.Sever spinal stenosis.Bilateral leg radiculopathy/numbness.Failed non operative treatment.On (b)(6) 2013: patient consulted with physician.Review of systems: leg weakness, numbness, chronic back pain, erectile dysfunction.Assessment: severe back issues, spinal stenosis, status post decompression laminectomy at l1-s1 with durotomy.On (b)(6) 2013: patient under went ct scan of abdomen and pelvis.Impression: very large amount of retained forces, consistent with con stipation.Distended gallbladder.On (b)(6) 2013: patient presented for consultation for constipation and urinary retention.Patient had laminectomy 1 week ago, l2 to sacrum with decompression.Intraoperative durotomy was noted and repaired.Patient reported difficulty urinating after surgery after which patient presented to er multiple times next week and catheterizations performed.Patient was also having problems with constipation and malaise.Impression: urinary retention.Mild renal insufficiency.On (b)(6) 2013: patient presented for post surgery follow up with numbness around the anal area and primarily in his right groin and down his leg, but these are all improving.Patient feels washed out and slow.Assessment: severe spinal stenosis l3 to s1 with associated radiculopathy.Radiculopathy, improving.Bilateral numbness from the gluteal area to the feet.Numbness of lower limb.Muscle strength in lower extremities is equal and symmetrical.Loss of urinary function, improving.Positive bowel sounds in all quadrants.On (b)(6) 2013: patient presented for post surgery follow up.Patient had problems with bowel control and constipation, but that is resolved.Assessment: severe spinal stenosis l3 to s1 with associated radiculopathy, which is improving.Gluteal numbness is improving.Muscle strength in lower extremities is equal and symmetrical.Urinary function is improving.Bowel is moving normally.On (b)(6) 2013: patient presented for office visit with chief complaint of hard to urinate.This started after lumbosacral laminectomy.He cannot sense bladder fullness.Assessment: urinary retention.On (b)(6) 2013: patient under went x-ray lumbar spine.Impression: post surgical changes.On (b)(6) 2013: patient presented for follow up with numbness in the right gluteal region and has no control over bowel and bladders.Assessment: severe spinal stenosis, l1 to sacrum.Six weeks post lumbar decompression.Post op other surgical procedure intraoperative durotomy/primarily repaired.Urinary incontinence.Bowel incontinence.Patient presented for follow up with back pain.On (b)(6) 2013: patient presented for post surgery follow up.Patient had bowel and voiding difficulties.Patient also had some urinary incontinence, initially.Patient still has numbness down the leg.Assessment: status post l1 to sacrum lumbar post op other surgical procedure laminectomy/decompression complicated by intraoperative durotomy.History of urinary incontinence, clinically improving.Bowel incontinence, clinically improving.Bilateral leg radiculopathy, clinically improving.Patient presented for follow up with back pain.On (b)(6) 2013: patient presented for post surgery follow up and has difficulties with voiding and bowel movements.Patient also has some numbness throughout the right leg.Assessment: status post l1 sacrum laminectomy, superimposed by fusion from l4 to the sacrum.Status post spinal fusion.History of urinary incontinence.Bowel incontinence.Right leg radiculopathy.Radicular syndrome of lower limbs.Patient presented for follow up with back pain.Patient under went x-ray lumbar spine.Impression: post surgical change and degenerative change.On (b)(6) 2014: patient under went ct lumbar spine with contrast.Impression: postoperative change with pedicle screws at l4, l5 and s1 with posterior rods.No definite stenosis noted at l4-5 or l5-s1.Some scarring on the right at l5-s1.Severe central stenosis at l3-4 with surrounding density probably related to scarring.Prominent facet disease.Patient had laminectomies from l1 to s1.No abnormality in region of cauda equina.There is collection of contrast in the soft tissues posteriorly to the l4 vertebral body which could represent leakage from dural sac into soft tissues posteriorly.Patient also under went lumbar myelogram injection procedure.Impression: postoperative changes are present.Patient has some encroachment on right side of dural sac and on the right neural foramen at l5-s1.Severe central stenosis at l3 with cut off of the nerve root sleeves bilaterally.Some contrast leaking out of dural sac posteriorly into the subcutaneous soft tissues.It could represent a dural leak or extravasation of contrast.On (b)(6) 2015: patient under went ct lumbar spine with contrast.Impression: high grade central stenosis l3-4 with increasing arachnoiditis.Stenosis is product of facet overgrowth and hypertrophic bone growth following decompression and bony fusion posteriorly.Neural foraminal stenosis right greater than left from hypertrophic new bone growth and otherwise intact l4 to s1 posterior decompression and pedicle screw fixation and fusion.Central stenosis is limited to focal mid l5 vertebral body compression by soft tissue material and bone.Arachnoiditis and epidural scar are considered as pre dominant findings.Lumbar lordosis is straightened.There is progression of hypertrophic bone growth and persistence of rather significant central stenosis l3-4.Patient also under went ct cervical spine with contrast.Impression: cervical straightening without fracture or spondylolisthesis.Normal craniocervical junction, c1 and c2.In general there is trace degenerative change at c2-3.Most significant lesion as at c3-4 where there is midline spur and broad based disc protrusion creating mild spinal cord compression.C4-5 level shows some uncovertebral over growth and mild neural foraminal narrowing on the right as well.Patient under went myelogram at multi levels.Impression: l4 to s1 pedicle screw fusion with posterior decompression.Some irregularity due to hypertrophic bone and scar tissue is seen.Right side leg anesthesia reported, stable appearance of amputation of the right side descending s1 root incidentally.High grade stenosis at l3-4 above the fusion was the greater finding along with lateral compression by hypertrophic new bone.No dural leak identified and the right s1 root amputation appeared to be related not only to hypertrophic bone but also to soft tissue density at l5-s1.Patient also under went ct thoracic spine with contrast.Impression: small spur t11-12 with only minimal thecal compression and no cord compression.Normal caliber spinal cord and spinal canal throughout the thoracic region.Well aligned thoracic vertebral bodies and normal disc spaces except for some diffuse mild endplate irregularity which is a degenerative process.No fracture, tumor or congenital lesion.Paraspinal exam is negative except for thoracic aortic aneurysm, this appears to be a diffuse process, but mild 3-3.4 cm measurements noted.On (b)(6) 2015: patient under went cta pelvis with and without contrast.Impression: left s1 pedicle screw impinges upon the left iliac vein by at least 5mm.There may be actual venous puncture by this pedicle screw.No hematoma at this site.Right pedicle screw at s1 has transcortical extension, but no proximity to vascular tree.Bilateral l4 and l5 pedicle screws are in good position without any other vascular compromise.Incidental coccygeal tip fracture is there and minimal diverticular disease.
 
Event Description
It was reported that on, (b)(6) 2008: the patient was discharged.On (b)(6) 2008: the patient presented for an office visit for evaluation and management of recent episode of excessive bleeding during spine fusion surgery.On (b)(6) 2009: the patient presented for a follow-up and underwent physical examinations.Impression: mild chronic left l5 radiculopathy.On (b)(6) 2013: the patient presented for an office visit with chief complaint of left leg pain.Conclusion: left l3 radiculopathy, active and chronic.Left l5 radiculopathy, chronic, mild.On (b)(6) 2013: patient underwent ct of the chest with and without contrast.Impression: there is minimal to mild stranding density in the right lung base that could represent a combination of volume loss or scarring.No pulmonary emboli are detected.Patient underwent x-ray of chest.Impression: there is some stranding density in the right lung base may represent volume loss.Patient underwent ultrasound of deep venous system of lower extremities.Impression: no evidence for deep venous thrombosis in the lower extremities.On (b)(6) 2013: patient underwent x-ray of abdomen.Impression: nonspecific abdomen.Paucity of gas within the abdomen.Postsurgical change lumbar spine.On (b)(6) 2013: patient under went x-ray lumbar spine.Impression: post surgical changes.The patient presented for an office visit with complaint of experiencing hard to urinate.Impression: there was diminished disc space height at l4-l5.There was extensive laminectomy defect extending from the level of l1-l2 to the level of l5-s1.There was minimal to mild osteophytosis arising from several levels of lumbar spine.On (b)(6) 2014, (b)(6) 2015: the patient presented for a follow-up of lower back/bilateral leg radiculopathy.On (b)(6) 2014: patient presented for evaluation with complaint of low back pain and bilateral leg numbness and bowel/bladder problems.Diagnosis: spinal stenosis; cauda equina syndrome.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that on, (b)(6) 2009: patient underwent mri of right ankle due to injury, fall and concern for strain sprain injury.Impression: strain sprain injury with probably slight bone bruise on the talar side of the far distal subtalar joint; limited tibiotalar joint effusion; diffuse soft tissue edema about the ankle, mild strain sprain injuries of the tibiotalar and mild to moderate of the fibulotalar ligaments without a avulsion or disruption.On (b)(6) 2014: the patient presented for neurologic consultation regarding low back pain with radiation into the legs.
 
Event Description
It was reported that on (b)(6) 2009: the patient presented for consultation.On (b)(6) 2013: patient presented for office visit with chief complaint of hard to urinate.This started after lumbosacral laminectomy.He cannot sense bladder fullness.Assessment: urinary retention.On (b)(6) 2015: the patient underwent pharmacological stress test and gated spect imaging.Impression: normal myocardial perfusion imaging.No regional wall abnormalities.Attenuation artifact is diaphragmatic.On (b)(4) 2015: the patient presented with right leg pain and bowel and bladder incontinence.The patient underwent x-ray of lumbar spine due to back pain.Impression: postsurgical features of l2-l5 posterior decompression and l4-s1 posterior spinal fusion.No evidence of hardware failure.Trace retrolisthesis l4 on l5; trace anterolisthesis l3 on l4.The patient also underwent anteroposterior and lateral standing scoliosis views of lumbar spine due to back pain.Impression: spondylosis t8-t9.Loss of vertebral body height t11 and t12.Internal fixation hardware l4-s1 intact.Retrolisthesis grade 1 l1 on l2.Anterolisthesis grade 1 l3 on l4.Subtle rotoscoliosis convexity to the right apex of angulation l2-l3.
 
Event Description
It was reported that on, (b)(6) 2012, patient presented for evaluation of sinus congestion, facial pain, and posterior nasal drainage.On (b)(6) 2013, the patient presented with complaint of urinary retention, oral/throat burning.On (b)(6) 2013, patient presented for follow-up visit for right ear pain from three days ago.Pain was described as mild, sharp, aching, constant and progressively worsening.On (b)(6) 2013, patient presented with complaint of slightly worsening right jaw pain.Patient reported sensation of some fluid in right ear.Patient underwent x-ray of mandible.Impression: negative x-ray of mandible.On (b)(6) 2014, patient presented for office visit.Patient reported high blood pressure, chronic low back pain, leg pain, neurogenic bladder, degenerative disc disease, spinal stenosis, multiple spinal fusions, decompressions, depression and anxiety.
 
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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 Key3898056
MDR Text Key4427053
Report Number1030489-2014-02940
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,Followup
Report Date 10/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/01/2010
Device Catalogue Number7510800
Device Lot NumberM110709AAG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/07/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/04/2008
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) Required Intervention;
Patient Weight131
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