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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 7510200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Muscle Spasm(s) (1966); Neuropathy (1983); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517)
Event Type  Injury  
Manufacturer Narrative
(b)(6).(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.
 
Event Description
It was reported that on (b)(6) 2006 patient presented with chief complaint of low back pain, bilateral leg pain.Review of musculoskeletal system: straight leg raising is positive bilaterally.No point tenderness along the lumbar spine.Review of neurological examination: motor exam-slight weakness in the left triceps and left wrist extensors as compared to the right; otherwise 5/5 in the upper extremities 5/5 in the lower extremities, except for tibialis anterior weakness at 4 to 4+/5.Reflexes-1+ throughout, except for absent patellar and ankle jerks on the right; down-going toes.On (b)(6) 2006 patient underwent mri cervical without contrast and lumbar spine x-ray.Impression: normal study.On (b)(6) 2006, (b)(6) 2006 patient presented for follow-up visit with history of back pain.On (b)(6) 2006 patient underwent mri brain without contrast.Impression: 1.Pansinusitis.2.No acute intracranial pathology is observed.On (b)(6) 2006 patient underwent chest, pa and lat exam.Impression: normal two view chest without change from prior study.On (b)(6) 2006 patient presented with chief complaint of back pain, numbness in legs.Patient also complaints of pain in his left arm from his shoulder to his fingers with numbness and tingling.Review of musculoskeletal system: straight leg raising is positive bilaterally.No point tenderness along the lumbar spine.On (b)(6) 2006 patient admitted.On (b)(6) 2006 patient presented with preoperative diagnosis of l4-5 central herniated disc.Operations: l4-5 tlif using cage, rh-bmp2/acs local bone, posterolateral fusion using local bone and allograft putty, pedicle screws, placement l4 and 5 bilaterally were expedium pedicle screws, bilateral laminectomies l4-5, bilateral discectomy l4-5.Per-op notes: surgeon explored the right l4-5 disk and there was a significant component of central disc herniation and even going bilaterally.Rh-bmp2/acs and local bone was placed anteriorly followed by placement of an 11 mm in length in height cage with rh-bmp2/acs and local bone.Local bone and allograft putty were placed bilaterally.Rods were placed, everything was tightened.No patient complications.Spine lumbar lateral test impression: lateral view of the lumbar spine demonstrates interval fusion at l4-5 with bony structures and hardware in apparent good position.On (b)(6) 2006 patient discharged.Conclusion: no significant change in tibial or nerve somatosensory evoked potential monitored throughout the operative procedure.On (b)(6) 2006 patient presented for follow-up visit with complaint of some left leg numbness.X-rays shows everything to be in satisfactory position.Lumbar spine x-ray findings: there are bilateral laminectomy defects at l4-5 and l5-s1.Metallic hardware and graft material extend posterolaterally from 14 to l5.Intervertebral spacers or intervertebral cages are identified within the l4-5 disc space.On (b)(6) 2008, (b)(6) 2008, (b)(6) 2008, (b)(6) 2008, (b)(6) 2008, (b)(6) 2008, (b)(6) 2008 patient presented with chief complaint of: low back pain, bilateral leg pain, neck pain and shoulder pain.Constant, numbness, pins and needles, muscle pain, sharp, throbbing, sharp, stabbing, spasm.Review of neurological system: gait: gait is neither non-antalgic nor broad base and the patient is able to heel-and-toe-walk normally.Assessment/diagnosis: lumbosacral spondylosis, chronic neuropathy in other, chronic tear med menisc knee-cur, acute shoulder dislocation - left, improved.Left persistent insomnia, chronic.Carpal tunnel syndrome, chronic.- right and left ulnar nerve lesion, chronic cervical spondylosis without myelopathy, chronic.On (b)(6) 2007, (b)(6) 2007 patient presented for follow-up visit.On (b)(6) 2007 patient underwent lumbar w/o bli <(>&<)> bending 7v.Impression: 1.Posterior interbody fusion at l4-5 with expected postoperative appearance of the hardware and interbody titanium cage.No fracture or subluxation noted.2.Nonspecific, mild ll-2 and l2-3 disk-space narrowing.On (b)(6) 2007 patient underwent ct l-spine w/o contrast, ct recons w/o post process.Findings: sagittal and coronal reformatted images are acquired.There is a posterior spinal fusion with dorsal plate and pedicle screw devices.There is an intra-diskal fusion of the l4-5 disk space.L4-5: post-laminectomy changes are noted.There is sclerosis about the facet joints at this level.No evidence of spinal stenosis is seen.Here is clumping of the nerve roots at this level which is suggestive of arachnoiditis.On (b)(6) 2009 patient presented with chief complaint of: low back pain, bilateral leg pain, neck pain and shoulder pain.Constant, numbness, pins and needles, muscle pain, sharp, throbbing, sharp, stabbing, spasm.Review of neurological system: gait: gait is neither non-antalgic nor broad base and the patient is able to heel-and-toe-walk normally.Assessment/diagnosis: lumbosacral spondylosis, chronic neuropathy in other, chronic tear med menisc knee-cur, acute shoulder dislocation - left, improved.Left persistent insomnia, chronic.Carpal tunnel syndrome, chronic.- right and left ulnar nerve lesion, chronic cervical spondylosis without myelopathy, chronic.On (b)(6) 2010 patient presented with chief complaint of: low back pain, bilateral leg pain, neck pain and shoulder pain.Constant, numbness, pins and needles, muscle pain, sharp, throbbing, sharp, stabbing, spasm.Review of neurological system: gait: gait is neither non-antalgic nor broad base and the patient is able to heel-and-toe-walk normally.Assessment/diagnosis: lumbosacral spondylosis, chronic neuropathy in other, chronic tear med menisc knee-cur, acute shoulder dislocation - left, improved.Left persistent insomnia, chronic.Carpal tunnel syndrome, chronic.- right and left ulnar nerve lesion, chronic cervical spondylosis without myelopathy, chronic.On (b)(6) 2011 patient presented with complaint of back pain and leg symptoms.Review of neurological system: headaches.Review of p sychiatric: depression.On (b)(6) 2011, (b)(6) 2012 patient presented with chief complaint of: low back pain, bilateral leg pain, neck pain, foot pain and shoulder pain.Constant, numbness, pins and needles, muscle pain, sharp, throbbing, sharp, stabbing, spasm.Review of neurological system: gait: gait is neither non-antalgic nor broad base and the patient is able to heel-and-toe-walk normally.Assessment/diagnosis: lumbosacral spondylosis, chronic neuropathy in other, chronic tear med menisc knee-cur, acute shoulder dislocation - left, improved.Left persistent insomnia, chronic.Carpal tunnel syndrome, chronic.- right and left ulnar nerve lesion, chronic cervical spondylosis without myelopathy, chronic.Impression: 1.The appearance of posterior appliance surgery at the level of l4-5 is unchanged.2.There is no suggestion of appliance instability.3.Flexion extension motion in spine segments above the level ofl4 appears adequate.Impression: 1.The appearance of posterior appliance surgery at the level of l4-5 is unchanged.2.There is no suggestion of appliance instability.3.Flexion extension motion in spine segments above the level of l4 appears adequate on (b)(6) 2012 patient presented with low back pain and bilateral radiculopathy.Review of neurological system: negative.Review of musculoskeletal system: muscle or joint pain, neck or back pain.On (b)(6) 2012 patient presented with following procedure: lumbar facet joint nerves (medial branch) injections of l4, ls, and 81 left side.Pre procedure diagnosis: lumbar facet syndrome and spondylosis.On (b)(6) 2012 patient presented with chief complaint of: low back pain, bilateral leg pain, neck pain and shoulder pain.Numbness, pins and needles, muscle pain, sharp, throbbing, sharp, stabbing, spasm.Review of neurological system: gait: gait is neither non-antalgic nor broad base and the patient is able to heel-and-toe-walk normally.Assessment/diagnosis: lumbosacral spondylosis, chronic neuropathy in other, chronic tear med menisc knee-cur, acute shoulder dislocation - left, improved.Left persistent insomnia, chronic.Carpal tunnel syndrome, chronic.- right and left ulnar nerve lesion, chronic cervical spondylosis without myelopathy, chronic.On (b)(6) 2012 patient presented with following procedure: myelogram, lumbar.Conclusion: 1, moderate spinal stenosis at l3-4 with 3 to 4 mm posterior subluxation of lj on l4, 2, bilateral laminectomies at l4-5 with anterior and bilateral posterior lateral spine fusion.Ct post mylo/disco- lum spine w.Findings: conus medullaris: normal, parasplnal area: normal.Vertebra: normal unless specified below.Impression: 1.Bilateral laminectomies at l4 and l5 with anterior fusion at l4-s.2.Bulging annulus and 3 to 4 mm posterior subluxation of l3 on l4.On (b)(6) 2012 patient for follow-up visit.Conclusion: patient with adjacent level problems above previous fusion at l4-5 with l3-4 moderate spinal canal and foraminal stenosis with posterior subluxation of l3 on 4.On (b)(6) 2013 patient presented with preoperative diagnosis of: lumbar stenosis, lumbar adjacent level disease, status post l4-5 fusion in the past.Procedure: l3-4 transforaminal lumbar interbody fusion with globus rods, cage and local bone, l3-4 posterolateral fusion with local bone and allograft bone, globus pedicle screw placement bilaterally at l3, bilateral laminectomies l3-4 with left l3-4 facetectorny, foraminotomy and discectomy, removal of old rod between ia-s and placement of new rod between l3 to l5 bilaterally.Conclusion of radiology: no significant change in tibial nerve somatosensory evoked potential monitoring throughout the operative procedure.On (b)(6) 2013 patient presented with chief complaint of: low back pain, bilateral leg pain.Numbness, pins and needles, muscle pain, sharp, throbbing, sharp, stabbing, spasm.Review of neurological system: gait: gait is neither non-antalgic nor broad base and the patient is able to heel-and-toe-walk normally.Assessment/diagnosis: lumbosacral spondylosis, chronic neuropathy in other, chronic tear med menisc knee-cur, acute shoulder dislocation - left, improved.Left persistent insomnia, chronic.Carpal tunnel syndrome, chronic.- right and left ulnar nerve lesion, chronic cervical spondylosis without myelopathy, chronic.Lumbar spine x-rays: x-rays show l3 -l5 posterolateral instrumented fusion with tlif.Satisfactory postop appearance.On (b)(6) 2013 patient presented for follow-up visit with chronic pain.Lumbar spine x-rays: ap and lateral lumbar spine x-ray from southwest neuroscience is reviewed showing l3-l5 fusion.All of the hardware is in good position.On (b)(6) 2013 patient presented for follow-up visit with muscular pain and some back pain.Lumbar spine x-rays: ap and lateral lumbar spine x-ray from southwest neuroscience is reviewed showing l3-l5 fusion.All of the hardware is in good position.On (b)(6) 2014 patient presented with chief complaint of: low back pain, bilateral leg pain.Numbness, pins and needles, muscle pain, sharp, throbbing, sharp, stabbing, spasm.Review of neurological system: gait: gait is neither non-antalgic nor broad base and the patient is able to heel-and-toe-walk normally.Assessment/diagnosis: lumbosacral spondylosis, chronic neuropathy in other, chronic tear med menisc knee-cur, acute shoulder dislocation - left, improved.Left persistent insomnia, chronic.Carpal tunnel syndrome, chronic.- right and left ulnar nerve lesion, chronic cervical spondylosis without myelopathy, chronic.
 
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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
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5063250
MDR Text Key25223770
Report Number1030489-2015-02262
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
Report Date 08/17/2015
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 Expiration Date12/30/2007
Device Catalogue Number7510200
Device Lot NumberM115009AAC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/09/2015
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) Other;
Patient Weight79
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