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

Catalog Number 7510400

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

Patient Problems Chest Pain (1776); Cyst(s) (1800); Edema (1820); Headache (1880); Nausea (1970); Neuropathy (1983); Vomiting (2144); Weakness (2145); Burning Sensation (2146); Stenosis (2263); Shaking/Tremors (2515); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

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 the patient underwent posterior lumbar fusion surgery at l4-s1 wherein rhbmp-2/acs was placed in the posterolateral gutters outside cage from a posterior approach.Post-op, the patient experienced progressively worsening low back pain, with pain, radiculopathy and weakness in her lower extremities, and pain radiating up into her thoracic region.The patient continued to experience chronic low back pain, with shooting and stabbing pain and radiculopathy into her buttocks, legs and feet.She experienced weakness in her right leg and her leg gave out on her.She had difficulty sitting, standing and walking and occasionally required a cane to assist in ambulation.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on: (b)(6) 2007: the patient was admitted with degenerative disk disease, l4-5 and l5-s1 and with the following preoperative diagnosis: diskogram, concordant pain, l4-5, l5-s1 and recurring fusion of the l4-5 and l5-s1 disk interspaces.She underwent the following procedure: posterior fusion with instrument from l4 to the s1 with left iliac crest bone graft, supplemented by bone morphogenic protein.Anterior lumbar diskectomy and fusion, l4-5 and l5-s1, with anterior interbody fusion spacers, anterior plating, l5-s1, with small stature plate for buttressing.Anterior extrapertioneal exposure of the l4-5 and l5-s1 disk interspace.Per op notes: ".The facet joint were denuded of their capsule at l4-5 and l5-s1.The articular cartilage was rongeured.After this, bone graft obtained from the left posterior ileum.Standard cortical and cancellous strips were obtained.She did not have lot of bone.She had a fairly horizontal sacrum.Because of this the doctor elected to supplement the autogenous bone with bone morphogenic protein.Using a medium-size kit, the sponges were soaked with the bone morphogenic protein and allowed to sit for about 20 minutes." no complications were reported.On (b)(6) 2007: the patient was discharged.On (b)(6) 2007: the patient presented with pain in down the right legs along the posterior thigh and calf, which, at times, was burning.X-rays showed excellent position of the screws.Progressive consolidation of the fusion was noted.On (b)(6) 2007: the patient presented for follow up due to fusion surgery.She was having a little bit of back pain and some aching in the legs.She underwent the x-ray.It showed progressive consolidation of her fusion.On (b)(6) 2007: the patient presented with some swelling and pain on the right side of her leg, along the buttock, posterior thigh and calf area.She underwent x-ray.It showed the fusion was solid.Assessment: lumbar disc degeneration; backache.On (b)(6) 2007: the patient presented with follow up due to right sided pain.She also had a little bit of burning.On (b)(6) 2008: the patient presented with follow up due to leg pain.X-rays showed that fusion was solid.Assessment: lumbar disc degeneration; backache.On (b)(6) 2008: the patient underwent ct scan of the lumbar spine without contrast due to lumbar pain and right leg pain.Impressions: anterior and posterior effusion changes at l4, l5 and s1.The components appear well-seated and aligned without evidence for complication.No evidence for residual or recurrent stenosis at these levels.The l1-2, l2-3 and l3-4 levels are normal without evidence for herniation or stenosis.On (b)(6) 2008: the patient presented with right leg pain.She underwent x-ray and ct myelogram.A-p and x-rays showed a complete healing of fusion.On (b)(6) 2009: the patient presented with right leg pain.She underwent x-ray and ct myelogram.X-rays showed that the fusion was solid.On (b)(6) 2009: the patient underwent lumbar ct scan and lumbar myelogram due to right l5 stenosis.Findings: right l5 stenosis.There was a diaphyseal graft at l4-5 and l5-s1.On (b)(6) 2010: the patient presented with low back pain which was emanating above her fusion possibly facet joint.She underwent the following operation: selective facet injections at lumbar 3-4 bilaterally.No complications were reported and visual analog scale did not change.On (b)(6) 2010: the patient presented with the following diagnosis: status post lumbar spinal reconstruction surgery with pain probably emanating above the fusion at l3-4 on the right.She underwent selective transforaminal injection at l3-4 on the right side.No complications were reported.On (b)(6) 2011: the patient presented with following diagnosis: essential tremor and chronic leg pain.She was also diagnosed with low back pain and insomnia.On (b)(6) 2012: the patient presented with exacerbation of lumbar radiculitis and low back and leg pain emanating above the previous fusion.She underwent selective transforaminal injection at lumbar 3-4.No complications were reported.On (b)(6) 2012: the patient underwent mri of head due to tremors.Impression: intracranial contents within normal limits.Trace of mucosal thickening inferior right mastoid air cells.Left mastoid air cells are paranasal sinuses appear clear.On (b)(6) 2012: the patient for a follow-up of head twitching.Impression: tremor, hand and head, most likely idiopathic.Small "mgus".Lumbar degenerative disc disease.Low back pain and "it" pain.On (b)(6) 2012: the patient presented with head and hand tremor, idiopathic she also had problems with "it" band withering.She underwent x-ray of the ankle due to ankle pain.Conclusion: there is an achilles tendon spur; there is an old avulsion fracture or accessory ossicle adjacent to the anterior aspect of the distal tibia; no evidence for fracture.On (b)(6) 2012: the presented with chest pain, migraine headache and arm pain.She underwent x-ray of chest.Impression: negative.On (b)(6) 2012: the patient underwent ct scan due to chronic sinusitis and history of left orbital fracture.Impression: sinuses are clear.Orbital floor fracture on the left.On (b)(6) 2013: the patient presented for consultation of monoclonal gammopathy.On (b)(6) 2013: the patient underwent mammogram screening.Finding: breast parenchymal pattern was heterogeneous which decreases the sensitivity of the modality; in the right breast upper outer quadrant, there is a well-circumscribed mass.On (b)(6) 2013: the patient underwent ultrasound mammogram screening of right breast due to mass in the upper outer right breast.Conclusion: 5mm cyst corresponds to the mammographic abnormality.On (b)(6) 2013: the patient presented with low back pain and left leg pain.On (b)(6) 2014: the patient presented with chronic low back pain.She underwent physical therapy.On (b)(6) 2014: the patient presented for office visit due to head tremor.On (b)(6) 2014: the patient presented with foot pain.She underwent x-ray of foot.Impression: no fracture was found.On (b)(6) 2014: the patient presented with right foot ankle pain.X-rays showed a bone palpable prominence of the lateral aspect of the calcaneus.Assessment: mass of foot, right.Edema.Difficulty in walking.Hypertrophy of bone.On (b)(6) 2014: the patient presented with following pre-operative diagnoses: bone mass right foot.Hypertrophy of bone, right foot.Difficulty walking.Edema, right foot.She underwent the following procedures: excision of bone mass, right calcaneus.C-arm intra-operatively.No patient complications were reported.She was discharged on the same day.On (b)(6) 2014: the patient presented for follow-up regarding exostectomy: dorsal lateral.On (b)(6) 2014: the patient presented for follow-up regarding exostectomy: dorsal lateral, right midfoot, foot and calcaneus.On (b)(6) 2014: the patient presented for fitness evaluation for the surgery of spinal cord stimulator placement.On (b)(6) 2014: the patient presented for placement of a spinal cord stimulator.On (b)(6) 2014: the patient underwent the following procedures: percutaneous implant electrical array epidurally.Percutaneous im plant electric array epidural.Insertion of neuro-stimulator generator.Implant spinal cord stimulator thoracolumbar.#2 leads.No patient complications were reported.On (b)(6) 2014: the patient presented with headache in the back of head.The back incision looked without erythema.On (b)(6) 2014: the patient presented for a follow-up status post spinal cord stimulator placement.She had mild pain just above the spine incision.On (b)(6) 2014: the patient underwent ct scan of thoracic spine due to mid-thoracic back pain.Conclusion: no acute fracture or subluxation of the thoracic spine; anticipated post-[procedural changes related to spinal stimulator device placement, entering the posterior spinal canal at the level of the t11-t12, and extending cephalad along the dorsal epidural space to the level of the t7 vertebral body.On (b)(6) 2014: the patient underwent bilateral full field digital screening mammogram with tomosynthesis.Findings: the breasts have scattered fibroglandular densities; there is no radiographic evidence of malignancy.On (b)(6) 2014: the patient presented with some bilateral thoracic pain that occurred when stimulators was on and this was minimal when off.The back pain was the main complaint, with some radicular features down the right leg.Pertinent imaging revealed: no acute fracture or sublaxation of the thoracic spine.Anticipated post-procedural changes related to spinal stimulator device placement, entering the posterior spinal canal at the level of t11-t12, and extending cephalad along the dorsal epidural space to the level of the t7 vertebral body.On (b)(6) 2014: the patient presented with chief complaint as having stimulator removed.She was scheduled for a surgery for removal of stimulator.On (b)(6) 2015: the patient presented for evaluation of headache.Diagnoses: orthostatic headache.Postoperative "csf" leak.She also complained of nausea and vomiting.On (b)(6) 2015: she presented for office visit due to back and radiating leg pain.On (b)(6) 2015: the patient underwent mri of thoracic spine due to mid-low back pain.Conclusion: normal thoracic cord.No pathological enhancement.No significant canal or foraminal narrowing at any level.On (b)(6) 2015: the patient presented with thoracic or lumbosacral neuritis or radiculitis, chronic back 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: 5149120
• MDR Text Key: 28234801
• Report Number: 1030489-2015-02667
• 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: Followup
• Report Date: 04/04/2016

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 Date: 10/01/2009
• Device Catalogue Number: 7510400
• Device Lot Number: M110604AAG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2007
• 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: 81