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

Catalog Number 7510200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Spasm(s) (1966); Neuropathy (1983); Burning Sensation (2146); Tingling (2171); Ambulation Difficulties (2544)

Event Type  Injury  

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.

Event Description

It was reported that on (b)(6) 2007, patient underwent spine fusion surgery on the lumbar region of her spine from vertebrae l5 to s1.Reportedly, during the surgery, rhbmp-2 and collagen sponge was used to treat patient via posterior approach.Allegedly, patient's post-operative period has been marked by chronic back pain with radiating pain to her right leg; burning, spasms, numbness and tingling in her right leg; numbness in her right foot; difficulty walking, sitting and standing for extended periods; periodic use of a cane to assist in ambulation; and depression.Patient alleged that severe pain and symptoms ultimately compelled her to undergo a revision surgery, and subsequent placement of a dorsal column and peripheral nerve stimulator.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on: (b)(6) 2006 the patient underwent mri of the lumbar spine.Impressions: small central disc protrusion/herniation at l5-s1 that is minimally increased since (b)(6) 2005.Associated disc desiccation and mild disc space narrowing at l5-s1, as before.Mild bilateral lower lumbar facet degenerative changes without impingement.Otherwise normal mri lumbar spine.On (b)(6) 2007, patient presented for office visit with complaint of back, hip and leg pain.Pain radiates from lower back to right lower extremity to outside of right foot.Patient underwent mri of lumbar spine w/o contrast due to pain.On (b)(6) 2007, patient underwent following procedure: l5-s1 complete laminectomy, l5-s1 complete discectomy.L5-s1 bilateral nerve root decompression, l5-s1 interbody arthrodesis utilizing banked allograft interbody devices, bmp and local autograft bone, l5-s1 pedicle screw fixation; for pre-op diagnosis of: l5-s1 degenerative disc disease.Per-op notes: ".The disc space was then sized and an 11 mm grafts were chosen and placed in bactrin irrigation for a minute.These were then packed with small bmp sponge which had been previously prepared.Using funnel and tamp, anterior disc space was filled with morsellized autograft bone.And a small piece of bmp sponge.On the right bed 11 x 10 mm interbody allograft filled with bmp was placed with a 1-2mm countersunk.Using funnel and tamp medial disc space was filled with morsellized autograft bone.And a small piece of bmp sponge.Then, from left side with the theca retracted and protected, a 10 x 22 x 11 mm allograft spacer was placed into the interspace after being filled with bmp sponge.It was also placed with 1-2 mm countersunk.Patient was transferred to recovery room in stable condition." on (b)(6) 2007, patient underwent colonoscopy with hot biopsy polypectomy.On (b)(6) 2007, patient presented for follow-up visit after l5-s1 lumbar interbody fusion.Patient reported some leg cramps, intermittent foot numbness.X-rays of lumbar spine showed hardware in stable position and graft well seated.On (b)(6) 2007, patient underwent echo with doppler, color fl mapping (echo), ltd eco with no doppler and doppler cardiac echo.On (b)(6) 2007, patient underwent x-ray of chest.Summary: no radiographic evidence of pulmonary disease.On (b)(6) 2007, patient presented for follow-up visit.On (b)(6) 2007, patient presented for follow-up six months after l5-s1 posterior lumbar interbody fusion.Patient reported pain that radiates from hip down to the lower extremities.Ap and lateral views of lumbar spine which showed stable hardware and interbody grafts at l5-s1 level with progressive bony fusion.On (b)(6) 2007, patient presented with complaints of back pain.Back pain radiates into the right gluteal fold and down to posterior lateral right thigh.Patient underwent right l4-5 and l5-s1 intra-articular facet steroid injection.On (b)(6) 2007, patient presented for follow-up two weeks after initial visit.Patient reported low back pain.On (b)(6) 2008, patient underwent mri of brain without gandolinium.Impression: no focal brain parenchymal lesions with mild right maxillary sinus mucosal thickening.Patient underwent mri of cervical spine.Impression: disc bulging diffusely at c4-5, greater toward the left than the right with mild impression upon the left neural foramen, minimal c5-6 and very mild c6-7 disc bulging as well.No focal cervical disc herniation is seen, minimal disc bulging is seen on the sagittal views to the left at midline at t3-4; narrowing of the disc space at the c4-5 with degenerative vertebral body osteophyte formation, greater anterior than posterior.On (b)(6) 2008, patient presented with complaints of neck and left shoulder pain.On (b)(6) 2008, patient presented for follow-up on neck shoulder and arm pain.On (b)(6) 2008, patient underwent following procedure: c4-5 and c5-6 complete anterior discectomy, bilateral neural foraminotomy, interbody arthrodesis using baked allograft structural spacer and anterior cervical plating with locking screws, use of operating microscope; for pre-op diagnosis of: c4-5 and c5-6 spondylosis and left sided neural foraminal narrowing.No complications were reported.On (b)(6) 2008, patient presented for first post-operative visit after c4-5 and c5-6 cervical discectomy and fusion.Patient underwent x-rays of cervical spine.Impression: anterior fusion of c4 through c6.Generalized straightening is present, with no focal bone abnormality.On (b)(6) 2009, patient underwent upper gi endoscopy procedure due to dysphagia.Impression: mild gastritis, large hiatal hernia and gerd.On (b)(6) 2009, patient presented for follow-up on neck surgery.Patient reported pain in left shoulder which increases after activity.Patient underwent x-ray of cervical spine, which showed anterior plate and screws with bone graft at disc spaces, status post fusion c4, c5, c6.Satisfactory alignment.On (b)(6) 2009, patient underwent mri of lumbar spine w/wo gandolinium.Impression: mild disc desiccation of the lumbar spine with no evidence of focal disc pathology or canal stenosis, mild dextrorotatory scoliosis of the lumbar column, status post posterior instrumented l5-s1 fusion.On (b)(6) 2009, patient presented for follow-up on two level anterior cervical discectomy and fusion and l5-s1 posterior lumbar interbody fusion.Patient underwent x-ray of cervical spine.Impression: anterior spinal fixation interbody fusion c4-6 in normal alignment.No significant change.Patient underwent ct of lumbar spine due to cervical spondylosis.Impression: intact l5-s1 anterior and posterior fusion with ¿cancal¿ decompression at l5 with solid bony fusion across the endplates at this level.No evidence of significant lumbar disc herniation, canal or foraminal stenosis.On (b)(6) 2009, patient underwent following procedure: right l5-s1 removal of instrumentation and exploration of nerve root, including foraminotomy at l5-s1, use of operating microscope; for pre-op diagnosis of: status post l5-s1 posterior lumbar interbody fusion with right l5 radiculopathy and foraminal stenosis.On (b)(6) 2009, patient presented for follow-up of hardware removal six weeks ago.On (b)(6) 2009, (b)(6) 2010, the patient was presented for office visit with right low back, buttock, hip, lower extremity pain for 8 months.Impressions: myalgia, myositis, enthesopathy of hip region, postlaminectomy syndrome of lumbar region, spasm of muscle, thoracic or lumbosacral neuritis or radiculitis, lumbosacral spondylosis without myelopathy, degeneration of lumbar or lumbosacral intervertebral disc, pain in limb, disturbance of skin sensation, spinal stenosis of the lumbar region.On (b)(6) 2009, the patient underwent trochanteric bursa injection(s) under ultrasound guidance ¿right piriformis muscle injection with ultrasound guidance.Pre-procedural diagnosis: myalgia and myositis, enthesopathy, post laminectomy syndrome of lumbar region, spasm of muscle, thoracic or lumbosacral neuritis or radiculitis, lumbosacral spondylosis, degeneration of lumbar or lumbosacral intervertebral disc, pain in limb and disturbance of skin sensation.On (b)(6) 2009 the patient underwent right l5 and s1 lumbar transforaminal epidural steroid injection(s) with fluoroscopic guidance and contrast control.Pre-procedural diagnosis: myalgia and myositis, enthesopathy, post laminectomy syndrome of lumbar region, spasm of muscle, thoracic or lumbosacral neuritis or radiculitis, lumbosacral spondylosis, degeneration of lumbar or lumbosacral intervertebral disc, pain in limb and disturbance of skin sensation.On (b)(6) 2009, patient presented for follow-up of right lower extremity pain.On (b)(6) 2009 the patient underwent percutaneous placement of 2x8 electrode dorsal column stimulation leads and 2x4 electrode peripheral nerve stimulation leads for trial under fluoroscopic guidance.Pre-procedural diagnosis: myalgia and myositis, enthesopathy, post laminectomy syndrome of lumbar region, spasm of muscle, thoracic or lumbosacral neuritis or radiculitis, lumbosacral spondylosis, degeneration of lumbar or lumbosacral intervertebral disc, pain in limb and disturbance of skin sensation.On (b)(6) 2009, patient underwent bilateral mammogram.On (b)(6) 2010, patient underwent following procedure: placement of dorsal column and peripheral nerve stimulator, leads and generator placement; for pre-op diagnosis of status post posterior lumbar interbody fusion with back and left greater than right lower extremity pain.On (b)(6) 2010, patient underwent ultrasound due to abdominal pain and vomiting.On (b)(6) 2010, (b)(6) 2011, (b)(6) 2012, the patient was presented for office visit with bilateral low back, buttock, hip and right lower extremity pain.Impressions: post laminectomy syndrome, pain in limb, enthesopathy of hip region, disturbance of skin sensation, degeneration of lumbar or lumbosacral intervertebral disc, chronic pain syndrome, neuralgia neuritis and radiculitis, spasm of muscle, spinal stenosis of lumbar region, myalgia and myositis, thoracic or lumbosacral neuritis or radiculitis, lumbosacral spondylosis, pain in thoracic spine, lumbago.On (b)(6) 2010, patient presented for follow-up post revision of dorsal column stimulator.Patient reported lack of stimulation in right leg where maximum pain is there.Patient underwent x-rays of thoracic spine three views which showed minimal scoliosis, degenerative disc disease, no fracture or dislocation and electronic stimulation device in place.On (b)(6) 2010, patient underwent procedure for revision of dorsal column stimulator lead for pre-op diagnosis of: status post dorsal column stimulator placement with migrated lead.No complications were reported.On (b)(6) 2010, patient presented for follow-up post revision of dorsal column stimulator.Patient presented for reprogramming.On (b)(6) 2011, patient presented for office visit with low back pain which radiates to lateral foot.Patient also reported sharp leg pain.On (b)(6) 2011, patient underwent x-ray of thoracic spine.Impression: the spinal stimulator leads are positioned at the mid thoracic spine.Patient underwent x-ray of lumbar spine.Impression: no acute findings.Spinal stimulator leads are seen overlying the psoas muscle.On (b)(6) 2011, patient underwent following procedure: removal of previous dorsal column stimulator, partial t8, t9 and t10 laminectomies with microscopic assistance, replacement of a new dorsal column stimulator and intraoperative programming; for pre-op diagnosis of malpositioned dorsal column stimulator.No complications were reported.X-rays of lumbar and thoracic spine from (b)(6) 2011 showed stimulator electrode at t5 and t6.On (b)(6) 2011, patient presented for office visit.Patient reported burning pain in left flank area.On (b)(6) 2012 patient was presented for office visit for bilateral low back, right posterior thigh, calf and lateral foot for many years.Impressions: lumbosacral spondylosis without myelopathy, myalgia and myositis, neuralgia neuritis and radiculitis, degeneration of lumbar or lumbosacral intervertebral disc.On (b)(6) 2013, patient underwent procedure for bilateral l4-5 and l5-s1 intra-articular facet joint injection, intraoperative fluoroscopy used for the procedure; for pre-op diagnosis of: lumbar spondylolisthesis.No complications were reported.On (b)(6) 2013, patient presented for office visit.Patient reported low back pain which radiates to right lower extremity and right foot.Pain increases on sitting and walking for long time and improves by changing position and lying on non-painful side.Patient also reported pain in hands, feet and leg.On (b)(6) 2014, (b)(6) 2013, patient presented for pain management for pain located in lower back on the right and left and was ranked as severe.Pain was described as lancing and sharp as well as dull and aching.On (b)(6) 2014, (b)(6) 2013, patient presented for pain management for pain located below the waist and in the right buttock.Pain described as deep, aching, throbbing pain.

• 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 Key: 5384968
• MDR Text Key: 36624890
• Report Number: 1030489-2016-00234
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2009
• Device Catalogue Number: 7510200
• Device Lot Number: M110602AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 71