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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Swelling (2091); Tingling (2171); Stenosis (2263); Depression (2361); Numbness (2415); Neck Pain (2433); Post Operative Wound Infection (2446); Nerve Proximity Nos (Not Otherwise Specified) (2647)
Event Type  Injury  
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.
 
Event Description
It was reported that on: on (b)(6) 2007 patient presented with following pre-op diagnosis: discogentic back and leg pain.Operation: provocative discogram.On (b)(6) 2007 patient presented for office visit because of persistent back and leg pain.On (b)(6) 2007 patient presented with following pre-op diagnosis: central disc herniation lumbar instability ia-l5, l5-s1, lumbar radiculopathy.Operation: lumbar fusion l4-l5, ls-s1 using spine exposure, minimally invasive xlif approach from the left and retroperitoneal for l4-l5 and retroperitoneal approach anteriorly at l5-s1.Interbody fusion using peak interbody fusion cage and bone morphogenic protein at l4-l5 and lordotic cages with bone morphogenic protein at l5-s1 with bilateral percutaneous pedicle screw fixation l1 to s1.Per-op notes: the trials were used to try to distract the disc space and use the right size, the ultimate size was the 10 mm height cage x 18 mm ap dimensions x 50 mm width.This was a peak cage packed with rhbmp-2/acs and graft.It was placed from last side all the way across the right side cage was tight and secure in very good position.Excellent position confirmed on final ap and lateral fluoroscopy.The degenerative herniated disc was removed, all the way back to posterior longitudinal ligament.The segment was unstable; it was distracted up to the 16 mm lordotic distraction wedge.Distraction was maintained by placing the drill tube through the interspace.The disc c space was reamed to the posterior margin, residual bone removed with disc biters.The cages were then placed, they were 20 mm length by 60 mm in diameter titanium threaded cages, lordotic cages, packed with rhbmp-2/acs and graft.Two cages were placed one on each side, they were tight and secure, in very good position.Other implants used cannulated multiaxial screws.On (b)(6) 2007 patient presented for follow up visit.Neurologically: intact.On (b)(6) 2007 patient presented with history of lower back pain.Impression: stable appearing l4 through s1 anterior and posterior fusion.On (b)(6) 2007 patient presented for visit with problems of leg, back <(>&<)> hip pain.On (b)(6) 2007 patient underwent lumbar ct.Impression: normal post-operative appearance after l4-5 and l5-s1 discectomies/interbody and posterior fusions.On (b)(6) 2007 patient presented for office visit.A lumbar ct scan shows a good bone fusion taking place through and around the cages at l4-5 and l5-s1 with very good position of the instrumentation.On (b)(6) 2007 patient underwent mri cervical spine.Impressions: minimal central protrusions c4-5 and c5-6 discs.Straightening in the sagittal sequence from the c4 to the c6 levels related to muscle spasm.On (b)(6) 2008 patient presented for office visit with low back pain.She has a lot of odd symptoms in her right arm with pain, pressure, numbness and tingling diffusely throughout her hands as well as sensations of tight muscles and ligaments.On (b)(6) 2008 patient underwent electromyography and nerve conduction studies.Impressions: normal nerve conduction study done in the right upper extremity.Normal needle emg study done in the right upper extremity.On (b)(6) 2008 patient underwent thoracic mri.Impression: minimal central protrusions t3-4 and t4-5 discs.On (b)(6) 2008 patient presented for office visit with severe neck and low back pain.She complains of numbness and tingling in her right hand.On (b)(6) 2008 patient underwent lumbar spine x-ray.Impressions: normal post-operative exam after l4-5 and l5-s1 discectomies and interbody/posterior fusions.On (b)(6) 2008 patient presented for office visit with problem of neck pain.On (b)(6) 2008 patient underwent lumbar ct.On (b)(6) 2008 patient underwent ct lumbar spine.Impressions: normal post-operative appearance after discectomies and interbody fusions at the l4-5 and l5-s1 levels, and posterior fusions at l4-5 level on the right and l4-s1 level on the left.On (b)(6) 2008 patient presented for office visit with problem of lot of low back pain.On (b)(6) 2008 patient presented for office visit with complains of pain on the right side.On (b)(6) 2008 patient underwent mri cervical spine.Impression: slight bulging of the c4-5 and c5-6 disc.No other abnormalities are demonstrated.On (b)(6) 2008 patient presented for office visit.On (b)(6) 2008 patient presented with following pre-op diagnosis: pain from pedicle screw instrumentation l4-s1 on the left, l4-5 on the right, lumbar radiculopathy.Operation: removal of pedicle screw instrumentation l4-s1 on the left, l4-5 on the right.Per-op notes: locking nuts were removed, as were the rods and screws on each side.The screws from l4-s1 on the left were removed and on the right.The l5 screw on the right had loosened.Solid fusion was present on pre-op.On (b)(6) 2008 patient presented for office visit.On (b)(6) 2008 patient presented for office visit.On (b)(6) 2008 patient underwent mri cervical spine without contrast with flexion and extension views.Conclusion: small right paracentral c5-6 disc herniation minimally indenting the anterior aspect of the thecal sac.Concentric bulging disc and annular tears involving the c4-5 level with no other sites of cervical disc herniation or cervical spinal stenosis or cervical cord compression.On (b)(6) 2008 patient presented for office visit.On (b)(6) 2008 patient underwent examination.Examination results: chronic cervical and thoracic dysfunction involving both articular and soft tissue; adverse neurotension.Very acute poor tolerance 10 min.Soft tissue mobilization.On (b)(6) 2008 patient presented for office visit.On (b)(6) 2008 patient underwent ct cervical spine w/o contrast.Impression: c5-c6 central disc herniation.The transverse foramina at these levels appear normal and symmetric.Examination: xr cervical sp completes with flex/ext.Impression: minimal spondolisthesis at c3-c4 on flexion view.On (b)(6) 2009 patient presented with following pre-op diagnosis: herniated disc c5-c6, cervical radiculopathy.Operation: anterior cervical micro discectomy, placement of artificial cervical disc (prodisc-c) c5-c6.On (b)(6) 2009 patient presented for office visit with complain of some mild dysphagia.On (b)(6) 2009 patient underwent cervical spine x-ray.Impression: normal post-operative appearance after c5-6 diskectomy and interbody fusion with disc device.On (b)(6) 2009 patient presented for office visit.She was complaining of residual lower back pain into her tailbone and down her legs.She complains of heel pain on the left side as well as dorsum of the foot pain on the right.She complains of upper extremity radicular symptoms as well.She was also complaining of some mild headaches.On (b)(6) 2009 patient underwent lumbar spine/sacrum x-rays.Impression: normal post-operative changes after l4-5 and l5-s1 diskecto mies/interbody fusions.Minimal scoliosis.On (b)(6) 2009 patient presented for office visit.On 23 apr 2009 patient underwent mri thoracic spine.Impression: negative thoracic mri.Thoracic spine x-ray impression: normal pot operative radiographs after c4-6 diskectomy and interbody fusion with disc device.On (b)(6) 2009 patient presented for office visit.On (b)(6) 2009 patient underwent lumbar spine x-ray.Impression: normal post-operative changes after l4-5 and l5-s1 diskectomies and interbody fusion.Cervical spine x-ray impression: normal post-operative appearance after c5-6 diskectomy and interbody fusion.Mild scoliosis with the convexity to the right.On (b)(6) 2009 patient presented for office visit.On (b)(6) 2009 patient presented for examination.Assessment results: cervical dysfunction involving the entire cervical and thoracic spine, both soft tissue and articular, with headaches.Soft tissue and articular dysfunction upper cervical.On (b)(6) 2009 patient underwent spine "cerv 2 or 3 vws".Impression: a prosthetic disc is inserted at the c5-c6 level.The hardware is in place, the alignment of the spine is stable with flexion and extension.On (b)(6) 2009 patient presented for office visit with complains of back and hip pain.On (b)(6) 2009 patient underwent ct lumbar spine.Impressions: l4-5 and l5-s1 intervertebral disc spacer and "diskectomies.Mild levoscoliosis".On (b)(6) 2009 patient underwent mri thoracic spine.Impression: there was no evidence of abnormality.On (b)(6) 2010 patient presented for office visit.On (b)(6) 2010 patient underwent examination with complaint of bilateral knee pain and bilateral foot pain.Review of neurological system: alert and oriented x3.Normal sensation to touch, temperature, vibration and pinprick in all four extremities.Proprioception is intact.On (b)(6) 2010 patient underwent right hip/pelvis x-ray.Impressions: normal pelvis.Mild degenerative changes of the right greater trochanter.On (b)(6) 2010 patient presented for follow up.On (b)(6) 2010 patient underwent thoracic spine x-ray.Impression: scoliosis and chronic compression fractures of the t7-t11 thoracic spine vertebral bodies.Mri can be performed for additional evaluation as clinically indicated.On (b)(6) 2010 patient underwent examination.Impression: pt with slowing of ulnar nerve across elbow bilaterally left severe, right mild.On (b)(6) 2010 patient presented for office visit.She continues to suffer from ongoing neck pain and paraspinal muscle spasms.This has been a very big problem for her in the entire trapezius muscles and across her shoulders.She also continues to complain of some low back pain.She does have a fusion at l4-5 and l5-s1.The l4 fusion as seen on the last imaging studies on (b)(6) 2010 patient presented with following pre-op diagnosis: right ulnar nerve entrapment at elbow.Right carpal tunnel syndrome, diagnosis code.Procedure performed: right ulnar nerve neurolysis at elbow.Right carpal tunnel release under general anesthesia and tourniquet control, diagnosis code.On (b)(6) 2010 patient presented for office visit.On (b)(6) 2011 patient presented for visit with problem of back pain.On (b)(6) 2011 patient underwent lumbar spine x-ray.Impression: normal post-operative changes after l4-5 and l5-s1 diskectomies and interbody fusion.On (b)(6) 2011 patient presented for office visit.Emg and nerve conduction studies show severe left ulnar nerve compression at the elbow.On (b)(6) 2012 patient presented for visit with neck pain.Ct cervical spine impression: normal post-operative changes after c5-6 diskectomy and interbody fusion with disc fusion devices.Cervical spine x-ray impression: negative radiographs of the cervical spine after cs-6 diskectomy and interbody fusion.On (b)(6) 2012 patient presented for office visit.On (b)(6) 2012 patient presented with following pre-op diagnosis: right cervical radiculopathy secondary to foraminal stenosis c5-c6 on the right.Operation: right posterior cervical foraminotomy c5-c6 under the microscope code.On (b)(6) 2012 patient presented with following pre-op diagnosis: posterior cervical wound infection.Operation: incision and drainage of posterior cervical wound.On (b)(6) 2012 patient presented for office visit.On (b)(6) 2012 patient underwent ct neck w contrast.Impression: patient status post-surgical prosthetic disc placement at c5-c6.Although there was respiratory motion the lung apices and streak artifact from dental fillings, no abnormal contrast enhancement of the soft tissues is noted.Ground glass opacity lung apices as described above.On (b)(6) 2012 patient presented for office visit.On (b)(6) 2012 patient presented with following pre-op diagnosis: recurrent posterior cervical wound infection with infection of c5-6 lamina, c7 spinous process, and epidural abscess.Operations: incision and drainage of posterior cervical wound infection with c5-6 laminectomy, evacuation of resection of epidural abscess, compression of spinal cord, resection of c7 spinous process.On (b)(6) 2012 patient presented with complaints of progressive swelling, erythema and pain in her neck.Impression: chronic osteomyelitis (b)(6) of the cervical spine c5-c6."dwelling" prosthetic disc c5-c6.High risk of infection related to above.Relapsed/failed 60 days of tv vancomycin following incision and drainage two and a half months ago.On (b)(6) 2012 patient presented for office visit.On (b)(6) 2012 patient presented with complaint of pain, cramping, dull, pressure, sharp.Review of neurological system: patient complaining of headache, insomnia, tingling, numbness.Review of psychiatric system: patient complaining of depression but medically treated.On (b)(6) 2012 patient presented for office visit.She has diffuse hives and swelling lips.On (b)(6) 2012 patient presented for office visit.On (b)(6) 2012 patient underwent l-s spine, ap and lat.Impression: surgical changes as above.A photic and distended stomach with a large amount of gastric content versus a moderate to large amount of colonic fecal content is suggested projecting over the left hemiabdomen.Spine, cerv 2 or 3 vws impression: increased vague soft tissue density in the posterior soft tissues with ill-defined poorly corticated spinous processes which are blunted at c5 and c6.Please correlate with prior surgical intervention an erosive osteolytic process such as osteomyelitis would also be a consideration.Stable prosthetic disc hardware at c5/c6, alignment of cervical spine is otherwise unremarkable.No loss of vertebral body height.On (b)(6) 2012 patient underwent ct lumbar spine.Impression: incomplete fusion at the l4-s1 level.Complete interbody fusion lit the l5-s1 level.Mild bulging l2-3 disc.Mild scoliosis with the convexity to the left.No evidence of spinal stenosis.On (b)(6) 2012 patient presented with chief complaint of neck pain, thoracic pain and back pain.On (b)(6) 2013 patient underwent mri thoracic spine.Impression: minimal, old t7 through t11 compression fractures, mild bulging t4-5 disc.Mild scoliosis.Mild scoliosis with the convexity to the left.Normal post-operative changes after l4-5 and l5 -s1 interbody fusions.Mri cervical spine impression: normal post-operative changes after c5-6 interbody fusion.On (b)(6) 2013 patient presented with chief complaint of cervical and lumbar pain.On (b)(6) 2013 patient underwent ct thoracic spine w/o contrast.Impression: no fracture seen.On 05 aug 2013 patient presented for office visit.On (b)(6) 2013 patient underwent mri thoracic spine.Impression: small central protrusion c4-5 disc.Minimal, old t8 through t11 compression fractures.Mri cervical spine impression: post-operative changes lifter c5-6 interbody fusion.No other abnormalities are demonstrated.Cervical spine x-ray impression: normal post-operative changes after c5-6 interbody fusion with disc fusion devices.Thoracic spine x-ray impression: minimal (less than 20%) t8 through t11 compression fractures.Mild scoliosis.Mild osteoporosis.Lumbar spine x-ray impression: normal post-operative changes l4-5 and l5-s1 interbody fusion.On (b)(6) 2013 patient presented for office visit.On (b)(6) 2013 patient presented with neck pain, thoracic pain and low back pain.On (b)(6) 2013 patient underwent mri lumbar spine.Impression: normal post-operative changes after 14-5 and l5-s1 interbody fusions.Mild scoliosis with the convexity to the left.On (b)(6) 2013 patient presented with chief complaint of thoracic pain, neck pain.
 
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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 Key5180916
MDR Text Key30021042
Report Number1030489-2015-02813
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 09/28/2015
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/28/2015
Initial Date FDA Received10/27/2015
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;
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