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

Catalog Number UNKNOWN

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

Patient Problems Nerve Damage (1979); Pain (1994); Seroma (2069)

Event Type  Injury  

Event Description

It was reported that the patient underwent a spinal fusion surgery via tlif at l2-l4 in which rhbmp-2 was used.The post-operative period was marked by bone mass and excessive fluid formation in the lumbar spine.As a result, the patient experienced severe back pain, nerve damage, and severe pain in his legs.The patient continues to experience severe back pain, nerve damage, and severe pain in his legs.This prevents him from practicing and fully enjoying the activities of daily life to the extent he did preoperatively.

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) 2011: patient presented with pre-op diagnosis: lumbar disc degeneration and post laminectomy syndrome.Patient underwent procedure: circumferential 360 degree anterior- posterior fusion: part (i).Anterior: 1.Hardware removal- anterior.2.Inspection of fusion mass.3.Lateral extracavitary discectomy l2-3.4.Lateral extracavitary discectomy.5.Partial corpectomy l3.6.Partial corpectomy l4.7.Arthrodesis l2-3.8.Arhtrodesis l3-4.9.Machined biomechanical spacer- peek.10.Machined biomechanical spacer- peek.11.Neuromonitoring.Part (ii) posterior: 1.Inspection of fusion mass.2.Hardware removal.3.Lamiectomies l2, redo laminectomies l3, l4, l5.4.Segmental spinal instrumentation l2-5.5.Arthrodesis l2-3, l3-4, l4-5 posterolateral.6.Autologous bone graft- same fascial incision.7.Bone marrow aspirate- pedicles.8.Intraoperative neuromonitoring.Per op-notes: ¿¿anterior: machined biomechanical peek spacer was tamped into position in the discectomy defect following removal of disc in its entirety.A machined biomechanical spacer was tamped into position at l2-3.This was filled with rhbmp-2/acs.¿¿.Posterior:¿4.Segmental spinal instrumentation l2-5.Placement under radiograophic guidance of screws into l2 bilaterally.Titanium rods were placed connecting each level (l2, l3, l5) on either side and locked into position using the locking screws.5.Arthrodesis l2-3, l3-4 and l4-5 posterolateral with autologous bone graft- same fascial incision.Autologous bone graft was harvested from the lamina and facets through the same fascial incision.This was morselized through the bone mill, mixed with rhbmp-2 and mozaik, and packed over the decorticated transverse processes of l2, l3, l4 and l5¿.¿ patient tolerated the procedure well.On same day patient was diagnosed with lumbar disc degeneration and underwent direct lateral retroperitoneal exposure l2-3 and l3-4.Patient¿s condition was stable post surgery.

• 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: 4265196
• MDR Text Key: 5297230
• Report Number: 1030489-2014-04472
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2017
• 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