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 Neuropathy (1983); Pain (1994); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

Patient code: (revision surgery, pseudoarthrosis).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) 2009 the patient underwent: removal of l5 pedicle screws and a portion of connecting rod bilaterally at l5.Reduction of grade 2 spondylolisthesis with posterior spinal fusion at l5-s1 using pedicle screw and rod instrumentation.Posterior lumbar antibody fusion with peek cage at l5-s1.Rhbmp-2 and vitoss reconstituted bone marrow harvested from the s1 pedicle.Preoperative diagnosis: post-laminectomy syndrome.Spondylolisthesis, l5-s1.Prior instrumented posterior spinal fusion with a retained pedicle screw and rod instrumentation from l3 through l5.As per op notes, ¿a large peek cage with bmp sponge was impacted across the discectomy site and the remaining disc space was filled with bmp sponge and vitoss.¿ on (b)(6) 2013 the patient underwent following procedures, anterior exposure for lumbosacral spine fusion (l5-s1), intraoperatively fluoroscopy.Vessel guard patch.Abdominal x ray reading.It was unusual anterior exposure for lumbar spine fusion (l2-4).Intra operatively fluoroscopy.Vessel guard x2.Abdominal x-ray reading.Preoperative diagnosis: degenerative lumbosacral spine (l5-s1).Degenerative lumbar spine (l2-4).Moderate aortoiliac arteriosclerotic disease and peripheral vascular disease.On (b)(6) 2013 the patient underwent following procedures: anterior arthrodesis with approach at l2-3 with interbody fusion with 14x27x30 mm, 10 degrees, oblique interbody peek cage filled with morselized autograft and allograft.Anterior arthrodesis with approach to l3-4 with an l3-4 interbody fusion with a 16x27x30mm, 10 degrees, oblique interbody peek cage filled with morselized autograft and allograft.Anterior arthrodesis to l5-s1 with removal of prior interbody hardware and redo interbody fusion within an 18x30x39mm, 10 degree, oblique peek cage filled with morselized autograft and allograft.Anterior fusion l2-3, l3-4 and l5-s1.Use of intraoperative fluoroscopy.Use of neural monitoring.Preoperative diagnosis: l5-s1 pseudoarthrosis.L2-3, l3-4 and l5-s1 degenerative disc disease.Lumbago.Radiculopathy.Treatment of refractory to conservative intervention.Failed back syndrome.As per op notes: ¿ we then placed a 16x27x30mm, 10 degrees, oblique peek cage filled with morselized autograft and allograft into the l3-4 disc space.We then deployed a plate to secure the l3-4 interbody cage into the l3 interbody.At this point, we moved up to the l2-3 disc space where again we confirmed our level using the lateral fluoroscopy.¿ on (b)(6) 2013 the patient underwent a posterior lateral arthrodesis only at l2-3, l3-4, l4-5, l5-s1 removal of posterior nonsegmental hardware across the single inner space at l4-5, posterior lumbar segmental instrumentation implanted at l2, l3, l4, l5 and s1.Spinal stereotaxy, complete laminectomy with bilateral recesses l2-3, microscope, same incision bone graft harvest, single small dose of bone morphogenic protein posterolaterally for pseudoarthrosis.Hardware implanted: pedicle screw instrumentation with crosslink.Preoperative diagnosis: lumbar pseudoarthrosis following fusion l3-4 and l5-s1, severe lumbar stenosis l2-3, neurogenic claudication, bilateral flailed feet and severe neural foraminal compromise at l5-s1.As per op notes: ¿the pedicle screws at l4-5 were exposed.The inter-spinous process spacer device below the spinous process of l2 was exposed, it was floating above l3.There was no bone below the inter-spinous process spacer and it was completely removed without difficulty.¿¿¿we then decorticated the facet joints at l2-3, l3-4, l4-5, l5-s1 for our posterolateral arthrodesis at l2-3, l3-4, l4-5 and l5-s1.We then placed bone autograft and a single small dose of bmp from l2 to s1.The sacral ala had been thoroughly decorticated as well.A large amount of bony allograft had been placed.¿.

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: 6492867
• MDR Text Key: 72777486
• Report Number: 1030489-2017-00884
• 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: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• 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: 03/20/2017
• 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; Required Intervention