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 Abdominal Pain (1685); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Spinal Column Injury (2081); Stenosis (2263); Numbness (2415); Osteopenia/ Osteoporosis (2651)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that on (b)(6) 2007, the patient presented for an office visit with chief complaint of lower back pain, right leg pain, numbness, tingling and weakness.Impression: right-sided lumbar radiculopathy.The patient underwent l5-s1 interlaminar injection under fluoroscopic guidance, right paramedian approach.(b)(6) 2007, the patient underwent ls-s1 interlaminar injection under fluoroscopic guidance.(b)(6) 2008, the patient presented for an office visit due to numbness and weakness.The patient underwent right l5 transforaminal injection under fluoroscopic guidance.(b)(6) 2008, the patient presented for an office visit due to low back pain.(b)(6) 2008, the patient underwent ct of lumbar spine w/contrast due to low back pain, right lower extremity pain.Impression: 1.Lumbar myelogram was performed without complication.2.There is no evidence of myelographic block.There are very minimal anterior extradural defects at l4-l5 and l3-l4.Impression:1.There is multilevel facet degenerative change greatest on the left at l5-s1, the right at l4-l5, and on the right atl2-l3.2.There is no significant central canal or neural foramina compromise, minimal narrowing of the anterior, inferior aspects of the neural foramina secondary to very minimal disc osteophyte complexes.(b)(6) 2008, the patient underwent ct abd/pelvis with contrast.Impression: 1 no significant ct abnormality of the abdomen is seen.Impression: 1.There is a 3 cm enchondroma of the proximal right femur which can be followed radiographically.2.No other acute ct abnormality the pelvis is seen.3.No soft tissue mass is seen.(b)(6) 2008, the patient presented for an office vist with chief complaint of right leg pain.Musculoskeletal, within normal limits.Neurological was essentially normal.(b)(6) 2008, the patient presented for an office visit.(b)(6) 2008, the patient presented for an office visit due to pain across her low back into right side of the hip.Impression: l5-s1 discogenic pain.(b)(6) 2008, the patient admitted to hospital with preoperative diagnosis l5-s1 diskogenic pain.The patient underwent following ope rations: anterior l5-s1 complete decompressive diskectomy; anterior l5-s1 interbody fusion with cage implantation and rh-bmp2/acs implantation; and anterior l5-s1 tension band instrumentation.Per op notes: it was found that a 15-mm 10-degree angle trial spacer gave good purchase of the bone above and below, 50 a 15-mm k2m cage that was 10 degrees angled was impacted with rh-bmp2/acs sponges and this was then impacted and countersunk into the disk space at l5-s1.(b)(6) 2008, the patient underwent x-rays of lumbar spine impression: anterior surgical fixation at the lumbosacral junction.Osteopenia.(b)(6) 2008, the patient presented for an office visit due to pain in her abdominal.Patient also complained of pain with bowel movements.Impression: the patient is doing well status post anterior lumbar interbody fusion l5 to s1.(b)(6) 2008, the patient presented for an office visit due to pain in her right flank.Impression: the patient is doing well status post anterior lumbar interbody fusion l5 to si.(b)(6) 2008, the patient underwent mri of lumbar spine.Impression postoperative changes at l5-s1.(b)(6) 2009, the patient underwent mri of lumbar spine.Impression normal postoperative lumbar spine.(b)(6) 2009, the patient presented for an office visit due to pain in her right hip and buttocks.Impression: the patient is stable status post anterior interbody fusion l5-s1.(b)(6) 2009, the patient underwent ap, lateral and lateral spot radiographs.Impression: postoperative changes at l5-s1.(b)(6) 2009, the patient presented for an office visit due to pain in upper thoracic region primarily on the right.Impression: the patient is stable status post anterior lumbar interbody fusion at l5-si.(b)(6) 2011, the patient presented with chief complaint of lower back pain with spasms.Impression: lower back pain status post anterior lumbar interbody fusion on (b)(6) 2008 and right leg muscle spasm.Mrl showed artifact at l5-s 1 with mild degenerative disc disease.(b)(6) 2011, the patient presented for the follow up post epidurals of lumbar spine.Patient complained of pain at 6/10 to lower back.(b)(6) 2011 the patient presented for an office visit due to chief complaint of right leg pain.Impression: post laminectomy with l5 radiculopathy.(b)(6) 2011, the patient underwent mri of lumbar spine w/o contrast due to low back pain.Impression: they result in very mild central spinal canal stenosis at l3-l4 and mild central spinal canalstenosis at l4-l5.No significant neural foraminal stenosis is seen.The patient underwent x-rays of lumbar spine due to back pain.Impression: grade 1 spondylolisthesis of l4-ls.Anterior fusion of ls-s 1.(b)(6) 2011, the presented for an office visit due to lower back pain.Mri showed status post the l5-s1 fusion.Plain x-rays in flexion and extension which demonstrated a mild l4-l5 spondylolisthesis.Impression: it was possible that this patient is now suffering from discogenic pain and spondylolisthesis ofl4-l5.(b)(6) 2012, the patient presented for an office visit due to pain in the lower back down the lateral leg to the knee on the right side.(b)(6) 2012, the patient underwent ap upright and lateral neutral upright and lateral flexion upright and lateral extension upright lumbar spine views and lateral upright cone-down lumbosacral view.Impression: stable study.The patient underwent lumbar mylegram.Impression: lumbar myelogram demonstrates ventral extradural defects at l3-l4 and l4-ls.The patient underwent ct of lumbar spine with contrast due to low back pain.Impression: 1.Anterior fusion at the lumbosacral junction without complication.2.Mild degenerative changes in the lumbar spine are not significantly changed from the (b)(6) 2011, mrl.(b)(6) 2012, the patient presented for follow up of lumbar mylegram.Patient complained of lower back pain and right lateral thigh pain and numbness.Lumbar myelogram showed l3-l4 and l4-l5 ventral extradural defect, l5-sl fusion, degenerative disc disease, degenerative changes, and grade 1 anterolisthesis ofl4-l5.07 (b)(6), the patient underwent spinal cord stimulator due to chronic polyneuropathic pain and lumbar radiculitis.(b)(6) 2012, the patient presented with chief complaint of pain in lower back down right leg thigh.(b)(6) 2012, the patient underwent mri of thoracic spine without contrast.Impression:1.Linear focus of t2 hyperintensity within the spinal cord at the l1 level.Dedicated mri of the lumbar spine with and without contrast is recommended for further evaluation.2.Multilevel thoracic spondylosis as described above.(b)(6) 2012, the patient presented for an office visit due to pain in low back and right lateral thigh.Impression: lumbar radiculopathy ill a patient who had good relief with a spinal cord stimulator trial.(b)(6) 2012, the patient underwent mri of lumbar spine without and with contrast.Impression:1.Normal-appearing distal spinal cord, conus medullaris and cauda equina.2.Postop l5-s1 discectomy/fusion.3.Degenerative changes present at l4-l5 level.(b)(6) 2012 the patient presented for an office visit due to lower back and right hip pain.(b)(6) 2012 the patient presented with following preoperative diagnosis: lumbar radiculopathy.The patient underwent t9-ti0 thoracic laminectomies for insertion of surgical electrode and implantation of spinal cord stimulator with intraoperative programming, all performed under fluoroscopy.(b)(6) 2012, the patient underwent x-rays of thoracic spine.Impression: mild multilevel degenerative spondylosis.Posterior thoracic epidural stimulator electrodes are positioned at the t7-t8 disc space.The patient underwent x-rays of abdomen.Impression: unremarkable abdomen.(b)(6) 2012, the patient presented for follow up of post spinal cord stimulator on (b)(6) 2011.Patient complained of lower back pain, leg pain, and abdominal pain.(b)(6) 2013 the patient underwent x-rays of thoracic spine.Impression:1.Stable appearance of spinal stimulator.2.Mild multileve l thoracic degenerative disc change.(b)(6) 2013, the patient presented for follow up of post spinal cord stimulator.Patient complained of some pain to lower back and right leg to ankle.(b)(6) 2013, the patient presented for an office visit with chief complained of back pain, hip pain on the right.

• 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: 5143714
• MDR Text Key: 28043434
• Report Number: 1030489-2015-02629
• 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: 09/21/2015

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 Date: 08/01/2010
• Device Catalogue Number: 7510400
• Device Lot Number: M110704AAB
• 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
• Date Device Manufactured: 01/08/2008
• 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: 69