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 Stenosis (2263); No Code Available (3191)

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) 2008 the patient underwent the following surgeries: revision decompression for purpose of neural element decompression and correction of stenosis, l2 through s1, posterior lumber interbody fusions, left-sided approach, l2-3, with 15-mm t-plif and bone morphogenic protein and local bone, left-sided approach for l3-4 with 11-mm t-plif and bone morphogenic protein and local bone, right-sided approach for l5-s1 with 13-mm t-plif and local bone and bone morphogenic protein, removal of posterior segmental instrumentation, l3 to l5, with exploration of fusion, reinstrumentation with l2 through s1 segmental hardware and local bone to treat the following pre-op diagnosis: transition zone breakdown with l2-3 spinal stenosis and spondylolisthesis above previous l3 to 5 decompression and fusion, development of degenerative spondylosis, l5-s1, and foraminal stenosis, l5-s1, likely nonunion, l3-4, application and removal of cranial head tongs.Per operative notes: ¿¿we then performed the same procedure at l5-s1 and again, after interval shaving and end plate debridement, packed bmp, impacted this and local bone graft with a size 11-mm trial spacer and impacted a 13-mm t-plif spacer with excellent purchase¿ a bmp sponge was folded and inserted into this interspace followed by local bone graft, which was impacted, followed by placement of an 11-mm t-plif¿.We decorticated the posterolateral gutters and then placed local bone graft mixed with dbx on the right-hand side.On the left-hand side, we cut open a bmp sponge, laid this into the posterolateral gutter, and then folded it over local bone with dbx¿ the patient was returned to the recovery room in stable extubated condition¿¿ on (b)(6) 2009 the patient underwent the following surgeries: removal of segmental hardware, l2 through s1, and exploration of fusion, revision laminectomy for purposes of neural element decompression, l1 and l2, and decompression of l5-s1 with foraminotomy at l5-s1 bilaterally, posterior lumbar interbody fusion, left side l5-s1, with 13 mm transforaminal posterior lumbar interbody fusion (t-plif) and bone morphogenic protein, and right-sided approach l1-2 with 15 mm transforaminal posterior lumbar interbody fusion (t-plif) and bone morphogenic protein (bmp) and local bone graft, posterior segmental instrumentation, t10 through ileum, with titanium universal spine system (uss), pelvic fixation using iliac screws, and arthrodesis using posterolateral technique, local bone graft, dbx, chronos, t10 through ileum to treat the following pre-op diagnosis: l1 compression injury with disk intussusception and transition zone breakdown, l1-2, with central stenosis, status post l2 through s1 fusion, with likely nonunion, l5-s1.

• 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: 5665888
• MDR Text Key: 45479697
• Report Number: 1030489-2016-01451
• 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: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• 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: 04/25/2016
• 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