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

Catalog Number 7510100

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

Patient Problems Weakness (2145); Tingling (2171); Stenosis (2263); Inadequate Pain Relief (2388); Claudication (2550)

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 (b)(6) 2008 patient was admitted to hospital in emergency condition.On (b)(6) 2008 patient presented with the medical history of type ii or unspecified type diabetes mellitus without mention of complication, not stated as controlled, blind and low vision- retinitis pigmentosa, unspecified essential hypertension, chronic airway obstruction, not elsewhere classified.On (b)(6) 2009 patient called to hospital, dysthymic disorder.On (b)(6) 2009 patient presented for pre-op evaluation prior to surgery for spinal stenosis.On (b)(6) 2009 patient "was for" diagnosis of lumbar spinal stenosis of severe spinal stenosis at lumbar 4-5, moderate at 3-4 and l5-s1.His symptoms most closely mimic an l5 radiculopathy now, particularly on the left.On (b)(6) 2009 patient got admitted in hospital.A lumbar spine mri was obtained revealing severe spinal stenosis at lumbar 4-5, moderate at 3-4 and l5-5.Primary diagnosis: spinal stenosis.Procedure: bilateral l4-5 foraminotomy with fusion and plate.On (b)(6) 2009 patient presented with the pre-op diagnosis: lumbar spondylosis, neurogenic claudication.Lumbar 4-5 spondylolisthesis.Operation: lumbar 4-5 bilateral foraminotomies, inspection of disc space.Microdissection technique.Posterior lumbar intertransverse fusion, right, with rh-bmp2/acs, autograft and allograft.Plating at 4-5 spire.Procedure: a localizing x-ray was obtained; the lumbar region was sterilely prepped and draped.Subsequently, a 4 cm vertical midline incision was made based on a preoperative x-ray.Skin was divided with a 10 blade scalpel, subcutaneous tissues with cautery to the fascia.Subperiosteal dissection of l4 was done bilaterally.X-ray confirmed our location.The surgeon then freed the spinous process of 4-5.I then exposed the transverse processes of l4 and 5 on the right using an undercutting technique and not disturbing the tissue over the 3-4 facet.This area was decorticated.The microscope was now brought to the field.In this operation the microscope was essential to allow for careful handling of the neural structures and to allow for effective assistance.Under the operating microscope, the high speed drill was used to thin the inferomedial portion of the l4 lamina, first on the left, as well as the medial facet.The dissection was taken down to the joint.Then, the yellow ligament which was markedly redundant was thinned with multiple sweeps of the curet and then ultimately pierced vertically with the curet.This allowed for both the medial and lateral ligamentectomy.The wound was made hemostatic with powder and irrigated aggressively.Surgicel was placed in the foraminotomy zones.The interspinous ligament was then resected.A large spire plate was sized, compressed, and final tightened.The bone graft, rh-bmp2/acs, and allograft were then packed over the transverse processes that were previously decorticated.This went very nicely.We had excellent hemostasis.On (b)(6) 2008 patient presented with severe lumbar spinal stenosis with intermittent weakness and neurogenic claudication.Diabetes.Patient underwent the following procedure: epidural steroid injection (b)(6) 2008.Impression: severe lumbar spinal stenosis with intermittent weakness and neurogenic claudication.Type 2 diabetes mellitus.Hypertension.On (b)(6) 2009 patient presented for postop follow-up.His preoperative symptoms were decreased but not remitted.He was fatigued with decreased endurance due to deconditioning.He does not have left radiating leg symptoms but occasional right lateral thigh pain.Over-all he was better.However the patient denied fever or chills.On (b)(6) 2009, (b)(6) 2011 patient presented for xr lumbar spine 2 or 3 vw.On (b)(6) 2010 patient presented for medication refills.On (b)(6) 2011 patient presented due to back pain.He had numerous tests including mrl's and emg's.On (b)(6) 2011 patient continued to have paresthesias occasionally over the anterior thigh and at the calf and foot.Reportedly, he has central stenosis at 3-4 and possibly at 31-2.He also had difficulty with the left arm at this time and had an emg/nerve conduction study at that time as well.He feels that he has easy fatigability, particularly in the right leg.He had some sense that he had either myositis or some toxic myopathy or neuropathy.He requested refills of his pain medication.On (b)(6) 2011 patient called to report that his r leg pain is much more intense.On (b)(6) 2011 patient called to report that he had been weaker and had pain in his arms as well.On (b)(6) 2011 mri - l4/5 - unroofing of the intervertebral disc with small diffusely bulging disc <(>&<)> advanced facet arthropathy contributed to moderate-severe central canal stenosis with near circumferential effacement of the cerebral spinal fluid.Moderate-severe bilateral neural foraminal stenosis secondary to endplate remodeling <(>&<)> advanced facetarthropathy.On (b)(6) 2011 patient had undergone ct guided right l4 and right l5 sensory nerve root injections.Patient pain was moderately better overall but he had a lot of numbness and tingling.On (b)(6) 2012 patient had pain from r hip to knee- states that leg is weak and calf muscle was "half the size of the other leg- but that this sx is not new"- pt denies foot drop and states there was no impairment of coordination.On (b)(6) 2012 mri - l4-5: reveals epidural fibrosis at the operative site extending into the right lateral recess <(>&<)> median right neural foramen.A diffuse disc bulge osteophyte complex is seen.Moderate-severe central canal stenosis and moderate bilateral foraminal stenosis." on (b)(6) 2012 patient presented with both neck i left arm and right leg complaints (pain and paresthesias).With possible myositis or some toxic myopathy or neuropathy.He had an emg/nerve conduction study, which demonstrated polyneuropathy and the possibility of radiculopathy.At his last visit we ordered l4 and right l5 sensory nerve root injections.He had burning paresthesias in the r leg after 1/2 block walking and resolves with sitting.He described his pain as minor.Denies stiffness or coordination issues.No nit.L leg is asymptomatic.He denied back pain.He denied any fine motor coordination problems of his hands.There was no new bowel, bladder changes.He had a cardiac and pulmonary workup recently and he stated these were not abnormal.Impression of most recent imaging studies demonstrate: l spine mri- mild progression of degenerative disc disease with a new small right far lateral foraminal disc protrusion at l3-l4 and a disc protrusion at the far lateral right ls-s1 neural foramen, progressed compared to prior exam.Correlation with clinical symptoms needed.The central canal stenosis at the l3-l4 and l4-ls levels remains stable.C spine mri- overall, there has been little change compared to previous exam.Central canal stenosis is again seen at the c6-c7 level, similar to previous.There is mild progression of left foraminal stenosis at the c2-c3 level.No new disc herniation was seen.

• 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: 5143765
• MDR Text Key: 28083792
• Report Number: 1030489-2015-02632
• 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
• 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
• Device Catalogue Number: 7510100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2015
• 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 Number: 1
• Patient Outcome(s): Other
• Patient Weight: 88