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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 Edema (1820); Inflammation (1932); Neuropathy (1983); Pain (1994); Numbness (2415)
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2003, the patient was walking to a basement of a home when the stairs collapsed.Work related injury.(b)(6) 2003: the patient underwent x-rays due to chronic back and leg pain.Impression: minor degenerative changes of the cervical and thoracic spines.The patient also underwent mri of the lumbar spine.Impression: degenerative changes with ¿hnp¿ at l4/5.There is also some ligamentum flavum facet hypertrophy.(b)(6) 2004: the patient presented with aching pain on top of his left shoulder, numbness over the first three digits of the left hand and aching pain in low back.Mri of the lumbosacral spine showed desiccation of the l4-5 intervertebral disc with both anterior and posterior hypertrophic changes.Diagnosis: 1.Recent strain or sprain injury of the back secondary to an on the job fall.Spinal compression, fracture, or fracture dislocations must be ruled out.2.Chronic low back pain secondary to degenerative arthritis maximal at the l4-5 interspace.3.Kyphos scoliosis of the thoracic spine.(b)(6) 2004: the patient underwent x-rays of the thoracic and lumbar spine due to pain in the low back after fall.Impression: no abnormality is seen in plain films of the thoracic spine and lumbar spine.(b)(6) 2004: the patient underwent mri of the lumbosacral spine compared to study from (b)(6) 2001.Impression: small central disc herniation at l4-5 which has decreased slightly in size since the previous study.No evidence of additional disc herniations in the lumbosacral spine.(b)(6) 2004: the patient presented with severe low back pain that is exacerbated by riding in a motor vehicle or walking for short distances.Radiograms of the thoracic and lumbosacral spine showed a number of mild degenerative changes most pronounced in the thoracic area.Impression: subacute strain injury of the back with severe spasms of the paraspinal muscles superimposed upon chronic spondylosis.(b)(6) 2004: the patient presented with bilateral shoulder pain and pain in right leg.Patient stopped using lortab for pain relief.Diagnosis: subacute strain injury of the back complicated by severe paraspinal muscular spasm with underlying spondylosis of the thoracic and lumbar vertebrae.(b)(6) 2004: the patient presented with some gradual spontaneous improvement in his low back spasm.Diagnosis: 1.Subacute strain injury of the back complicated by moderate paraspinal muscle spasm, improving.2.Spondylosis of the thoracic and lumbar vertebrae.(b)(6) 2004: the patient presented with intermittent back pain and spasm.Diagnosis: 1.Chronic strain injury of the back complicated by pain and fluctuating paraspinal muscle spasm.2.Spondylosis of the thoracic and lumbar spine exacerbated by the patient's injury.The patient was prescribed a trial of a transcutaneous electric nerve stimulator unit as an additional mode of treatment.(b)(6) 2004: the patient has been undergoing regular physical therapy.Diagnosis: persistent lumbar spasm secondary to a sprain injury in (b)(6) 2003 superimposed on underlying lumbar spondylosis.(b)(6) 2004: the patient underwent mri of the lumbar spine without contrast due to low back pain.Impression: moderate diffuse posterior and biforaminal disc protrusion at l4-5, flattening the thecal sac and impinging upon the l4 spinal nerves; mild to moderate biforaminal narrowing at l4-5 and l5-s1.(b)(6) 2004: the patient presented with low back pain and bilateral anterior thigh pain.The patient also has leg weakness, leg pain, back pain, neck pain, swelling.Impression: low back and leg pain.(b)(6) 2004: the patient underwent a diagnostic discography.Impression: a relatively normal nucleogram at l4-5 and l5-s1, but a markedly abnormal nucleogram at l4-5 with spread of contrast within the annulus anteriorly and posteriorly and marked fissuring and loss of disc space height.(b)(6) 2005: the patient presented with low back and bilateral leg pain.The patient underwent a facet block.The patient underwent diagnostic discography in (b)(6).Impression: painful disc disruption syndrome at l4-5.(b)(6) 2005: the patient presented with preoperative diagnosis of painful internal disc disruption l4-5 as well as bilateral thigh pain.The patient reported with pain occurring in the lower lumbar line and anterior thighs with a sharp quality.The patient also reports memory disturbance, sinus problems, arm pain, neck pain, swelling, arthritis, and swelling of the feet.The patient underwent the following procedures: l4-5 posterior interbodyfusion and pedicle screw fixation; transforaminal placement of a peek capstone spacer with rhbmp-2/acs sponge left l4-5; posterolateral fusion (morcellized local bone) left l4-5.Sextant instrumentation was used.Per the op notes, a peek capstone spacer was filled with two rhbmp-2/acs sponges.One bmp sponge was rolled up and placed across the midline through the opening, and another rhbmp-2/acs sponge was placed anteriorly within the disc space.Inserter was used to drive the capstone spacer into the disc space at a diagonal to cross the midline.A lateral fluoroscopic image demonstrated good positioning at the anterior aspect of the disc space, and this positioning maintained lordosis at the l4-5 level.No patient complications were noted.(b)(6) 2005: the patient presented complaining of left posterior leg pain.(b)(6) 2005: the patient presented with pain across low lumbar region.Pain in right buttock and legs seems to have resolved.(b)(6) 2005: the patient underwent x-rays of the lumbosacral spine due to back pain.Impression: 1.Patient is status post lumbar fusion at l4-l5 as described.2.The metallic rod coursing between the right pedicle screw of l4 and the right pedicle screw of l5 has somewhat pointed superior and inferior tips.Suggest correlation with surgical procedure and history.3.The l4-l5 disc space is slightly more narrowed in appearance on today's exam than previous exam.However, there is no obvious bony destructive change involving the endplates at the l4-l5 level.Suggest correlation with sed rate and clinical exam.(b)(6) 2005: the patient presented reporting he is worse with numbness involving both legs diffusely more on the left.He is experiencing severe bilateral hip pain and leg weakness.The doctor reviewed x-rays and no complications were noted.(b)(6) 2005: the patient underwent mri of the lumbar spine due to back pain.Impression: 1.Postop changes at l4-l5 are noted.Bone graft is seen at this level.Prior disc protrusion noted on the study of (b)(6) 2001 has since been resected, corresponding subchondral edema is appreciated on the stir weighted views mild edema in the region of the neural foramen of l4-l5 on the left side is seen on the stir weighted views.2.Mild foraminal narrowing of l4l5 on the right side and minimal foraminal narrowing of l5-s1 bilaterally is noted but not significantly changed from the prior study.Apparently, the patient had too much pain and refused iv contrast.(b)(6) 2005: the patient presented with intermittent left leg pain, but his symptoms have improved substantially.(b)(6) 2005: the patient underwent mri of the lumbar spine due to low back pain.Impression: very limited study obtained due to the patient¿s inability to tolerate the procedure, secondary to pain.Chronic degenerative disease at the l4-5 disc.The appearance of which is quite similar to (b)(6) 2005.Post op changes at l4-5.(b)(6) 2005 : the patient presented with low back and diffuse buttock, posterior thigh, and calf pain.The patient states that a workman¿s compensation doctor told him that one of the screw heads was prominent and may have been irritating the facet joint at the next level.The patient¿s medication avinza was increased to 60 mgs daily.The doctor reviewed the follow up x-rays which reveal no change in position of the instrumentation.The doctor advised patient to discontinue the use of his bone growth stimulator at any time.(b)(6) 2005: the patient underwent x-rays of the lumbar spine.Impression: status post lumbar fusion.(b)(6) 2005: the patient presented with increasing low back and leg pain.The patient states he has stopped his avinza.There was a noted regarding the patient¿s radiological reviews that there was no evidence of nerve root compression.Diagnoses: low back and leg pain of unclear etiology.(b)(6) 2005: the patient presented with worsening pain in the low lumbar region through his buttock, posterior thighs, and calves and involves the plantar aspect of both feet as well as the dorsum of the right foot.Any activity increases pain.Avinza was decreased to 30 mgs daily.X-rays of an unknown date reveal a hint of bone growth in the interbody space at l4-5 and no change in position of the instrumentation.(b)(6) 2005: the patient presented and stated that his back pain that he was experiencing before surgery had improved, but he has been plagued by significant bilateral lower extremity pain of unclear etiology.(b)(6) 2006: the patient presented stating he has discontinued his avinza.The patient hydrocodone dosage was increased to 10/ 325 mg.The doctor reviewed x-rays of the patient that show there appears to be a pilosity of bone.(b)(6) 2006: the patient underwent ct scan of the lumbar spine without contrast.Impressions: 1.Status post discectomy and cage device insertion at l4-5 with posterior fusion.The alignment is normal and there is no hardware complication.(b)(6) 2006: the doctor reviewed the patient¿s ct from an unknown date.Findings: some evidence of fusion through the interbody spacer, though not as robust as we would like to see.(b)(6) 2006 : the patient reported with chest pain, positive weight change, numbness ,joint aching, swelling and spasm.Impression: 1.Chronic low back pain.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿.Opioid therapy was prescribed to patient.(b)(6) 2006: the patient was now under the care of pain management specialist.Since the patient was taking pain medications, the doctor reviewed the patient¿s blood chemistries from an unknown date in the sense of liver function and it appeared normal.(b)(6) 2006: the patient reported with chest pain, positive weight change, positive leg cramping, numbness, joint aching, swelling and spasm.Impression: 1.Chronic low back pain.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb.Opioid therapy was prescribed to patient and discontinued fentanyl.(b)(6) 2006: the patient called in to the doctor stating he has continued pain.(b)(6) 2006: the patient reported with tolerance to the opioid therapy.Impression: 1.Chronic low back pain.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb.(b)(6) 2006: the patient reported with back pain with radiation of numbness and tingling into his legs.Impression: 1.Chronic low back pain.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb.(b)(6) 2006: the patient reported with back pain with radiation of numbness and tingling into his legs.Impression: 1.Chronic low back pain.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb.The patient reported tolerance to the opioid therapy.(b)(6) 2006: the patient presented with chronic low back pain.Impression: 1.Chronic low back pain.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb.The patient discontinued hydrocodone 10/500.(b)(6) 2007: the patient reported with chronic low back pain with radiation of numbness and tingling into his legs.Impression: 1.Chronic low back pain.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb.(b)(6) 2007: the patient reported with chronic low back pain with radiation of numbness and tingling into his legs.Impression: 1.Chronic low back pain.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb.The patient discontinued du ragesic.(b)(6) 2007: the patient reported with increased back pain.Impression: 1.Chronic low back pain, failed lumbar fusion.2.Lumbar fusion l4- 5 with posterior instrumentation, 3.¿pvd¿ right lower limb status post bypass surgery.(b)(6) 2008: the patient presented with chronic back pain which is worsening with cold weather.Impression: 1.Chronic low back pain, failed lumbar fusion.2.Lumbar fusion l4-5 with posterior instrumentation, 3.¿pvd¿ right lower limb status post bypass surgery.The patient discontinued vicodin es.(b)(6) 2008: the patient presented with increased back symptoms.Impression: 1.Chronic low back pain, failed lumbar fusion.2.Lumbar fusion l4-5 with posterior instrumentation, 3.¿ pvd¿ right lower limb status post bypass surgery.(b)(6) 2008 : the patient presented with tingling and pain of the toes in the right foot.Impression: 1.Chronic low back pain, failed lumbar fusion.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb status post bypass surgery with neuropathy.(b)(6) 2008: the patient was still under rehabilitation.(b)(6) 2008: the patient complained of unusual body odor and increased back pain.Impression: 1.Chronic low back pain, failed lumbar fusion.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb status post bypass surgery with neuropathy.(b)(6) 2009: the patient underwent x-rays of lumbar spine.Impression: stable-appearing lumbar fusion.The patient also underwent serological testing due to ongoing complaints.Impression: discrete m protein noted.Interpretation: serum immunofixation pattern demonstrates an ¿igg¿ kappa monoconal protein.(b)(6) 2009: the patient complained of unusual body odor and increased back pain.Impression: 1.Chronic low back pain, failed lumbar fusion.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb status post bypass surgery with neuropathy.The patient underwent x-ray of the lumbosacral spine which reveals no instability.The serological testing did reveal abnormal protein profile.(b)(6) 2009/(b)(6) 2009/(b)(6) 2010: the patient complained of increased back pain.Impression: 1.Chronic low back pain, failed lumbar fusion.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb status post bypass surgery with neuropathy.Findings: vitamin d levels are normal, testosterone levels are borderline.(b)(6) 2010: the patient presented with increased back pain.Impression: 1.Chronic low back pain, failed lumbar fusion, flare-up.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb status post bypass surgery with neuropathy.(b)(6) 2010: the patient was doing remarkably well and his consumption of tylenol using percocet and vicodin es has been reduced dramatically.Impression: 1.Chronic low back pain, failed lumbar fusion, flare-up.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb status post bypass surgery with neuropathy.(b)(6) 2010: the patient¿s medication nucynta was increased to 100mg.Impression: 1.Chronic low back pain, failed lumbar fusion, flare-up.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb status post bypass surgery with neuropathy.(b)(6) 2010: the patient presented with trouble adjusting the nucynta 100 mg dose.Impression: 1.Chronic low back pain, failed lumbar fusion, flare-up.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb status post bypass surgery with neuropathy.(b)(6) 2011: the patient presented with trouble adjusting the nucynta.Impression: 1.Chronic low back pain, failed lumbar fusion, flare-up.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb status post bypass surgery with neuropathy.The patient discontinued nucynta.(b)(6) 2011: the patient discontinued oxycontin and he is doing somewhat better.Impression: 1.Chronic low back pain, failed lumbar fusion, flare-up.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb status post bypass surgery with neuropathy.(b)(6) 2011: the patient presented with neuropathic pain and stabbing pains in his feet.The patient underwent bypass surgery for peripheral vascular disease.Impression: 1.Chronic low back pain, failed lumbar fusion, flare-up.2.Lumbar fusion l4 5 with posterior instrumentation.3.¿pvd¿ right lower limb status post bypass surgery with neuropathy.(b)(6) 2011: the patient presented with low back pain.Impression: 1.Chronic low back pain,failed lumbar fusion, flare-up.2.Lumbar fusion l4 5 with posterior instrumentation.3.¿pvd¿ right lower limb status post bypass surgery with neuropathy.(b)(6) 2012 : the patient underwent ct scan of the lumbar spine without contrast compared to the mri study dated (b)(6) 2006.Impression: 1.Status post fusion of l4 and l5 vertebral bodies in good anatomic alignment.Presence of bone graft.2.Multilevel facet joint hypertrophy worse from l3 to l5-s1.3.Disc-osteophytic changes at l3-l4 without central canal stenosis.There is mild to moderate bilateral neural foramina stenosis.4.Moderate to severe left neural foramen stenosis at l4-l5 secondary to osteophyte and scar formation.There is no central canal stenosis.5.Vacuum phenomenon of the sl joint, left greater than right.The patient also underwent the following studies: 1.Sedimentation rate.2.Lymes titer.3.¿tsh¿.(b)(6) 2012: the patient presented with severe peripheral vascular disease status post femoral bypass.The patient also underwent surgery for the peripheral vascular disease.The cat scan of the lumbar spine reveals l4-5 disc degeneration/fusion and lateral recess stenosis on the left greater than right.¿tsh¿ is low and uric acid level elevated.Impression: 1.Chronic low back pain, failed lumbar fusion, flare-up.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ right lower limb status post bypass surgery with neuropathy.The patient discontinued percocet tablets.(b)(6) 2012: the patient presented with severe peripheral vascular disease status post femoral bypass.Impression: 1.Chronic low back pain, failed lumbar fusion, flare up.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ status post right and left lower limb post bypass surgery.4.Ischemic peripheral neuropathy.(b)(6) 2012: the patient complained that the oxycodone 30 mg is not beneficial in controlling the pain and he also had lumbar facet injections without improvement.Impression: 1.Chronic low back pain, failed lumbar fusion, flare up.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ status post right and left lower limb post bypass surgery.4.Ischemic peripheral neuropathy.(b)(6) 2012: the patient was doing somewhat better.Impression: 1.Chronic low back pain, failed lumbar fusion, flare up.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ status post right and left lower limb post bypass surgery.4.Ischemic peripheral neuropathy.(b)(6) 2013: the patient has been relatively stable with medication management for his chronic pain.Impression: 1.Chronic low back pain, failed lumbar fusion, flare up.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ status post right and left lower limb post bypass surgery.4.Ischemic peripheral neuropathy.(b)(6) 2013: the patient complained that the oxycontin has been ineffective.He suffers from chronic back pain and severe neuropathy.Impression: 1.Chronic low back pain, failed lumbar fusion, flare up.2.Lumbar fusion l4-5 with posterior instrumentation.3.¿pvd¿ status post right and left lower limb post bypass surgery.4.Ischemic peripheral neuropathy.The patient discontinued oxycontin.(b)(6) 2013: the patient¿s medication pregabalin was increased to 75 mg.Impression: 1.Chronic low back pain, failed lumbar fusion, flare up.2.Lumbar fusion l4 5 with posterior instrumentation.3.¿pvd¿ status post right and left lower limb post bypass surgery.4.Ischemic peripheral neuropathy.
 
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.
 
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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 Key4242754
MDR Text Key5047559
Report Number1030489-2014-04324
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 10/13/2014
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 NumberM114001AAG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/13/2014
Initial Date FDA Received11/11/2014
Was Device Evaluated by Manufacturer? No
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;
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