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); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Other event location other : unknown.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) 2009, patient underwent following procedure: posterolateral fusion l4-l5.Posterior spinal instrumentation using titanium 5.5 millimeter round l4-l5.Transforaminal interbody fusion through a right-sided approach l4-l5.Lnterbody instrumentation using avs cage l4-l5.Autologous local bone grafting augmented with rhbmp-2/acs and bone graft substitute; for pre-op diagnosis of: degenerative spondylolisthesis with spinal stenosis l4-5.Per-op notes: ".A longitudinal midline incision was then made at level at l4-l5, carried down to skin and subcutaneous tissues down to the fascia and down to the posterior elements.Intraoperative x-rays were taken, shows that we were at appropriate levels.Further dissection was then made to expose the transverse processes bilaterally.Following this we went ahead and decorticated bony endplates and inserted autologous morselized bone plus rhbmp-2/acs into the interspace then followed by the insertion of the avs cage.The avs cage used was a 12 millimeter height with a length of 25 millimeters.The cage was also packed with autologous bone.This went in, in the very acceptable alignment within the interspace of l4 and l5 as verified by the x-rays on both the pa and lateral projections.The area was then thoroughly irrigated and spinal canal was then inspected for any bony debris and was found to be clean.So the area was then covered with a thin layer of gelfoam.We went ahead and packed a 10, of autologous bone, rhbmp-2/acs and actifuse bone graft substitute to the gutter spanning the transverse process of l4 and l5 bilaterally.On the left facet joints there was some remaining bony surface.This was then decorticated and autologous bone rhbmp-2/acs was implanted with the hope of obtaining facet fusion.The patient tolerated the procedure well.There were no complications noted¿" on (b)(6) 2010, patient underwent following procedure: anterior diskectomy, l5-s1.Anterior interbody fusion, l5-s1.Interbody instrumentation using cage, l5-s1.Autologous local bone grafting augmented with rhbmp-2/acs and demineralized bony matrix; for pre-op diagnosis of: adjacent level degenerative disk disease, l5-s1, status post l4-5 fusion with solid arthrodesis.Per-op notes: ".We went ahead and did an anterior annulotomy and a very thorough diskectomy.We went ahead and decorticated the bony endplates and harvested the bone for autologous local bone.This was test morcellized, mixed with rhbmp-2/acs, and was placed inside the cage.The cage was then inserted into the space using the catalyst instrument in a very controlled manner.Cage went in the ideal and stable position.An additional local bone graft and dbm plus rhbmp-2/acs placed at the lateral aspect of the interspace and also anteriorly.The patient tolerated the procedure well.There were no complications noted.The patient underwent intraoperative x-ray that showed the very ideal position of the perimeter cage on the lateral x-rays." on (b)(6) 2010, patient underwent following procedure: 1.Removal of instrumentation, l4-l5.Exploration of fusion, l4-l5.Posterior spinal fusion, l5-s1.Posterior segmental spinal instrumentation, 5.5 mm rods regular screws at l4 and s1.Osteogrip screws at l5 l4-l5 and l5-s1.Bilateral foraminotomies of l5-s1.Autologous local bone grafting augmented with rhbmp-2/acs and demineralized bone matrix; for pre-op diagnosis of: adjacent lumbar degenerative disc disease l5-s1, status post l4-l5 fusion which showed arthrodesis with mechanical back pain and radiculopathy.Per-op notes: ".Screws were then inserted, which are 6.5 mm x 35 mm screws, both with good bony bites at s1.Went ahead and re-instrumented l4 with screws with a size of 6.5 mm x 40 mm length screws.Again both screws went in with very good bony bite.So following the decompression and decortication of the area, went ahead and packed rhbmp-2/acs, autologous morselized bone and demineralized bony matrix to span the fusion mass of l4 to the facet joint of l5-s1.On the right side we did a facet fusion at l5-s1.The patient tolerated the procedure well and there were no complications noted." on (b)(6) 2012, patient underwent following procedure: removal of instrumentation, l4-s1.Exploration and fusion, l4-s1.Posterolateral fusion, l2-l4.Posterior segmental spinal instrumentation using spinal instrumentation, 5.5 millimeter rods from l2-l3, l3-l4, l4-l5, and l5-s1.Autologous local bone grafting augmented with rhbmp-2/acs and demineralized bony matrix; for pre-op diagnosis of: lumbar spondylosis, adjacent level, with stenosis and retrolisthesis l2-l3, l3-l4, status post spinal fusion from l4-s1.Per-op notes: ".A longitudinal midline incision was then made from l2-s1.At this juncture we proceeded in doing a posterolateral fusion and not pursuing a transforaminal interbody fusion since we had good bony surface for fusion at the fusion mass bilaterally, opted the transverse process of l2 and also some bony surface in the facet joints.We did a fusion by applying a combination of rhbmp-2/acs, autologous local bone harvested from the decompression, and also demineralized bony matrix.The patient tolerated the procedure well.There were no complications noted." on (b)(6) 2013, patient underwent following procedure: anterior discectomy, l2-l3 and l3-l4.Anterior interbody fusion, l2-l3 and l3-l4.Interbody instrumentation using novell cage l2-l3 and l3-l4.Autologous local bone grafting augmented with rhbmp-2/acs and demineralized bone matrix; for pre-op diagnosis of: lumbar spondylosis status post spinal fusion, l2-s1 with pseudoarthrosis l2-l3 and l3-l4.Per-op notes: ".The approach was a left-sided retroperitoneal approach and following exposure of the disc space at l2-l3 and l3-l4, intraoperative x-rays were taken.We then decorticated the bony endplates and were able to harvest a copious amount of autologous local bone from the decortication.Then filled the appropriate size cages with autologous local bone, rhbmp-2/acs and demineralized bony matrix.We then inserted the cage into the disc space after confirmation of the sites using trials.The size of the cages were 12 millimeters in anterior height with a lordotic angle of 12 degrees and a medium footprint.Cage went in, in a very stable manner in the ideal position within the interspaces of l3-l4 and l4-l5.Additional bone graft was placed on the left anterolateral aspect with a combination of demineralized bony matrix, and also autologous local bone.The patient tolerated the procedure well.There were no complications noted.".

• 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: 5482972
• MDR Text Key: 39742820
• Report Number: 1030489-2016-00614
• 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
• Report Date: 02/16/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 03/07/2016
• 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): Other