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 Headache (1880); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Stenosis (2263); Discomfort (2330)

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.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) 2013: the patient presented with the following diagnosis: severe low back pain and occasional left leg pain; history of l4-5 microdiskectomy; small recurrent l4-5 disk herniation; degenerative disk l4-5.The patient underwent the following procedures: l4-5 posterior spinal instrumented fusion using pedicle screw instrumentation and use of local autograft; l4-5 transforaminal lumbar interbody fusion using the peek interbody cage and extra small rhbmp-2 and local autograft; revision l4-5 laminectomy and discectomy.Per op-notes: ¿¿next we carefully mobilized the l5 nerve root medially and incised the disk space with a #15 blade knife followed by pituitary rongeurs, angled curettes, and a disk space shaver and carefully prepared the endplates slightly bleeding bone and tailed up to a 12mm cage.Once inside the cage, we placed extra small lit of rhbmp-2, slip one small sliver for placement inside the right l4-5 facet joint as well.We carefully impacted this as far anteriorly and rotated as possible and we were pleased with our position.We next applied our l5 screws bilaterally.¿¿ on (b)(6) 2013: patient was discharged from the hospital.On (b)(6) 2013: patient presented for his 12-day post op visit.Patient described having discomfort and lot of pain.Impression: low back pain; improvement in left lower extremity symptoms; fusion after prior discectomy at the left l4-5 level.On (b)(6) 2013: patient presented for med relief and asked for a prescription for his oxycodone.Impression: status post lumbar laminectomy and transforaminal lumbar interbody fusion for recurrent disk herniation; left greater than right lower extremity pain; back pain.On (b)(6) 2013: patient presented for a 6-week post-op checkup.Patient described having significant amount of pain.On (b)(6) 2013: patient presented for med relief.He described severe pain after walking too much.On (b)(6) 2013: patient presented with a follow-up visit.Impressions: broad-based moderate disk protrusion at l4-5 slightly eccentric to the right paracentral location which is new from the previous exam of (b)(6) 2011.Stable left foraminal disk protrusion at this level is again noted; mild relative central canal stenosis at l2-3 and l3-4 with mild to moderate relative central canal stenosis at l4-5 is noted.Stable mild degenerative disk changes at t11-t12.On (b)(6) 2013: patient presented with a follow-up visit due to back pain and leg pain.Impressions: status post l4-5 laminectomy fusion and tlif; chronic residual back pain; facet asymmetry/ facet disease l5-s1.On (b)(6) 2013: patient presented with a ct of the lumbar spine without and with contrast due to low back pain and status post l4-5 tlif.Impressions: at l4-5, there is interbody fusion.There is also posterior fusion with bilateral pedicle screws and spinal rods.Bilateral laminectomy defects are noted.The central spinal canal and neural foramina are widely patent; at l5-s1, there is facet arthropathy.There is a diffuse posterior bulging annulus with a small, superimposed posterocentral disc protrusion.This appears slightly more pronounced than on previous study.The neural foramina are within normal limits.On (b)(6) 2013: patient presented with a follow-up visit due to medication refill.Impressions: status post lumbar laminectomy and fusion; left lower extremity radiculopathy; low back pain; facet arthropathy.On (b)(6) 2013: patient presented with follow-up visit due to low back pain and left leg pain.Impression: chronic l4 radiculopathy on the left hand side which is causing paresthesias but no pain.On (b)(6) 2013: patient presented with follow-up visit due to low back pain and left leg pain.Impression: the patient is suffering from degenerative disk disease and chronic neuropathic pain on the left side.On (b)(6) 2013: patient presented with follow-up visit due to low back pain.Impression: chronic back and occasional left leg pain; status post l4-5 revision laminectomy, fusion and transforminal lumbar interbody fusion; questionable painful hardware; moderate adjacent level facet disease, l5- s1.On (b)(6) 2013: patient presented with follow-up visit due to low back pain.Impressions: degenerative disc disease of the lumbar spine; status post l4-5 lumbar fusion; facet joint arthropathy.On (b)(6) 2013: patient presented with the following pre-op diagnosis: adjacent level facet disease l5-s1; chronic back pain; questionable hardware; status post previous l4-5 fusion.Patient underwent following procedures: bilateral facet joint injections; bilateral hardware injection at l5 level.Patient tolerated the procedure well.On (b)(6) 2013: patient presented for a follow-up visit.Impressions: status post facet injection with aggravation of his back pain; history of lumbar laminectomy and discectomy with fusion, possible painful hardware.On (b)(6) 2013: patient presented with follow-up visit due to low back pain.Impressions: status post facet injections and painful retained instrumentation injections; history of lumbar fusion and discectomy with l4-5 posterior rod and screw instrumentation; headaches.On (b)(6) 2013: patient presented with follow-up visit due to increasing low back pain.Impressions: chronic pain; cervical headaches.On (b)(6) 2014: patient presented with follow-up visit due to low back pain.Impressions: status post l4-5 lumbar fusion; chronic pain; cervical headaches.On (b)(6) 2014: patient presented with a follow-up visit due to low back pain and headaches.Impressions: chronic back pain with occasional leg pain, worse with sitting; status post l4-5 revision laminectomy, fusion and tlif; questionable painful hardware; moderate adjacent facet disease l5-s1.On (b)(6) 2014: patient presented with an mri of the lumbar spine without and with contrast due to displaced degenerative lumbar intervertebral disc.Impressions: l3-4: there is posterolateral annular bulge of disc.The central spinal canal and foramina appear patent; l4-5: there are post surgical changes.Plate and screws transfix the vertebral bodies.The central spinal canal and foramina appear patent; l5-s1: there is posterocentral annular bulge of disc which does not touch or efface the dural sac or exiting nerve roots.On (b)(6) 2014: patient presented with an office visit for back pain evaluation.Impressions: degenerative disk disease lumbar spine; facet joint arthropathy.On (b)(6) 2014: patient presented with an office visit due to low back pain.Impressions: status post l4-5 laminectomy, fusion and tlif done for recurrent disk herniation and chronic back pain; mild adjacent disk degeneration/ disk desiccation; questionable painful hardware.On (b)(6) 2014: patient presented with an office visit due to low back pain and left leg pain.Patient also underwent a physical examination.Impressions: history of tlif at l4-5; mild early disk desiccation l2-3 through 4; persistent back greater than left leg pain; lumbar radiculopathy; muscular spasms.On (b)(6) 2014: patient presented with ct lumbar spine post disco gram due to back pain and degenerative disc disease.Impressions: stable pedicle screw and rod fixation spanning l4-5 with interbody fusion at this level; at l2-3 the contrast material extends to the posterior and right lateral peripheral disc margin consistent with annular tearing/ fissuring.No evidence of disc bulge or focal disc protrusion.The central spinal canal and neural foramina are normal, stable; at l4-5, left laminectomy defect, stable.There is stable left foraminal endplate osteophyte formation; at l5-s1 there is a small broad based right forminal/ lateral disc protrusion with annular tear, moderate right facet arthropathy and mild left facet arthropathy, resulting in mild right neural foraminal narrowing.These findings do not definitely impress upon nor displace the right l5 nerve root.The central canal and left neural foramen are normal.On (b)(6) 2014: patient presented with an office visit due to low back pain.Impressions: patient is status post l4-5 lumbar fusion; degenerative disk disease lumbar spine; chronic pain.On (b)(6) 2014: patient presented with an office visit due to chronic low back pain.Impressions: status post l4-5 laminectomy, fusion and transforaminal lumbar interbody fusion, done for recurrent disk herniation and chronic back pain; adjacent level facet joint degeneration and disk herniation and annular tear at l5-s1; chronic 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.

• 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: 5989741
• MDR Text Key: 55991506
• Report Number: 1030489-2016-02730
• 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: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: 7510100
• Device Lot Number: M111209AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2013
• 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