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

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

Patient Problems Edema (1820); High Blood Pressure/ Hypertension (1908); Pain (1994); Chronic Obstructive Pulmonary Disease (COPD) (2237); Stenosis (2263); Anxiety (2328); Neck Pain (2433); Sleep Dysfunction (2517)

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.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) 2004, the patient presented with discogenic low back pain.Following procedures were performed; laminotomy l4-5 ; posterior fusion l1-s1/ pelvis with left iliac crest bone graft, two large kit bmp, 20cc bone graft matrix, tsrh instrumentation with 2 "spirous" 90d crosslinks from stryker.Per operative notes, ".The surgeon removed the facet joints at 1-2, 2-3, 3-4-4-5,5-1.These were then decorticated with a high speed bur and packed with local bone.The surgeon has prepared two large kits of bmp per protocol, and these small slivers of bmp were packed within the facet joints themselves.A brief laminotomy was performed bilaterally at l4-5 and decompression was performed uneventfully.Pedicle screws were then placed at l1, l2, l3, l4, l5, s1 and pelvis.The rod was then threaded into position and into all screws.All the hardware's were torqued appropriately.The surgeon then decorticated the remainder of lamina with an osteotome and placed a layer of bmp and iliac crest bone followed by more bmp local bone and bone graft." on (b)(6) 2004: patient underwent ct of lumbar spine without contrast due to back pain.On (b)(6) 2004 the patient underwent study of the lumbar spine.Impression: l3-s1 diskectomies and anterior fusion of l1 through s1 and both iliac bones.On (b)(6) 2004 the patient underwent ct exam of the lumbar spine without contrast.Impression: status post anterior interbody fusion at l5-s1, l4-5 and l3-4.Status post multi-level posterior fusion with posterior instrumentation.On (b)(6) 2004 the patient presented for follow up visit due to discogenic low back pain.On (b)(6) 2005 the patient underwent ct examination of the lumbar spine without contrast.Impression: status post anterior interbody fusion at l5-s1.L4-5 and l3-4: no evidence of device loosening.Bony bridging is evident across the disk space at each level.Multi-level interlaminar/posterolateral fusion.Questionable right sided for-lateral disk herniation at l2-3 with potential impingement upon right l2 or l3 nerve roots.Clinical correlation is suggested.On (b)(6) 2007, the patient presented with complaint of chest discomfort as well as right flank pain.The patient underwent radiograph of chest.Impression: no acute cardiopulmonary disease.Evidence of prior granulomatosis.On (b)(6) 2007, the patient presented with chest pain and underwent myocardial perfusion imaging.The patient underwent presantine cardiolite stress teat.Impression: normal myocardial perfusion imaging.Normal left ventricular ejection fraction and normal wall motion.Impression (presantine) : negative.On (b)(6) 2007, the patient presented due to chronic neck and back pain.On (b)(6) 2007, the patient presented for follow up.Patient complaint of anxiety.Impression: chronic intermittent low back pain; htn; dislipidemia ; copd ; alcohol dependence ; insomnia.On (b)(6) 2007, the patient presented for evaluation of his low back pain.Impression: copd, tobacco abuse, anxiety, insomnia.On (b)(6) 2008, the patient presented with complaint of major back pain.On (b)(6) 2008 the patient was administered injection left pelvic screw in l5-s1 facet, left.On (b)(6) 2008, the patient presented for pre-op evaluation.The patient was scheduled for hardware removal from his low back on (b)(6) 2008.On (b)(6) 2008 the patient presented for follow up visit.On (b)(6) 2008, the patient presented with pre-op diagnosis of painful hardware and underwent removal of segmental fixation.Per op notes, ".Soft tissue was cleared free with the bovie and surgeon was able to loosen the pelvic screws using a high speed cutter.We were able to cut through the rod just caudal to the s1 screw bilaterally." on (b)(6) 2008, the patient presented with primary diagnosis of discogenic low back pain.Painful hardware, disc herniation t10, t11.On (b)(6) 2008 the patient presented for follow up of his chronic medical problem.Impression: failed back syndrome, major depression, insomnia, copd, htn, alcohol dependence.On (b)(6) 2008 the patient presented for follow up.The patient complaint of burning in his feet and mid back pain.On (b)(6) 2008 the patient underwent mri of the thoracic spine without contrast.Impression: lower cervical and lumbar fusion with instrumentation.T10-11 left paracentral disc herniation resulting in left ventral cord flattening and mild central canal stenosis.The herniation measured upto approximately 5mm in thickness.On (b)(6) 2008, the patient underwent mri of thoracic spine without contrast.Impression: lower cervical and lumbar fusion with instrumentation; t10-11 left paracentral disc herniation resulting in left ventral cord flattening and mild central canal stenosis.The herniation measured up to 5mm in thickness.On (b)(6) 2008, the patient presented with complaint of back pain, leg pain, numbness and weakness.Mri evaluation shows a large left t10-11 disc herniation which is paracentral.There is flattening of the cord.Impression: thoracic myelopathy secondary to large thoracic disc herniation t10-11.Fixed sagittal imbalance (mild).Previous fusion from l1 to s1/ilium-solid fusion.

Manufacturer Narrative

(b)(4) (leg pain), (disc herniation).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on, (b)(6) 2006, (b)(6) 2007: the patient presented for pain in right knee.On (b)(6) 2006: the patient underwent mri of right knee without contrast.Impression: probable degenerative fraying in the posterior horn lateral meniscus; acl laxity, despite intact acl fibers; mild, chronic mcl sprain; chronic proximal fibular collateral ligament injury with fibrosis; mild popliteus tendinopathy; moderate/marked chondromalacia patella.Mild chondromalacia in the lateral compartment; small knee effusion.On (b)(6) 2007: patient underwent mri of lumbar spine with and without contrast due to low back pain.Impression: there was no significant central spinal canal stenosis.Suggestion of minor left foraminal encroachment at l3-4 through l5-s1.Abnormal edema within the inferior right lateral endplate of t12 and superior right lateral endplate of t11.Minor compression deformities are suspected.Central disc herniation at t10-11 in association with facet hypertrophy contributes to mild cord compression and canal stenosis at the t10-11 level on the most superior aspect of the sagittal images.On (b)(6) 2007, the patient presented for evaluation of his low back pain.Impression: copd, tobacco abuse anxiety, insomnia.On (b)(6) 2007: the patient presented with left leg pain and low back pain.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5553664
• MDR Text Key: 42030343
• Report Number: 1030489-2016-00998
• 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,Followup,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• 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
• Date Manufacturer Received: 06/20/2016
• 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): Required Intervention
• Patient Weight: 83