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)

Event Type  Injury  

Event Description

It was reported that the patient underwent a tlif surgery at l2-l3 and l5-s1 in which rhbmp-2 was used.The post-operative period was marked by a development of an abnormal inflammatory response in the lumbar spine.As a result, the patient continues to experience severe back pain, chronic pain radiating to his arms and legs, nerve damage, and permanent disability.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.

Manufacturer Narrative

Add'l info.

Event Description

It was reported that on: (b)(6) 2006: patient presented with following pre-op diagnoses: spinal stenosis, severe, l2-3, 3-4, 4-5, l5-s1 status post four previous spinal procedures.For which, patient underwent following procedures: lumbar decompression extensively l2, 3-4, 4-5, l5-s1, four levels.Posterior lumbar interbody fusion l2-3 bilaterally with 10 mm bone grafts and l5-s1 with 10 mm bone grafts.Posterolateral fusion l2-s1 with autograft and allograft.Variable angle screw and rod fixation l2 to the sacrum, two crosslinks, cell saver, fluor.Per op notes, surgeon performed interbody fusion with 10 mm grafts restoring height at l5-s1 and lordosis with 10 mm grafts, rhbmp-2 and autograft.Posterolateral fusion was performed over the transverse processes l2-s1 with rhbmp-2, autograft and allograft and cortical cancellous supplementation.Patient tolerated the procedure well without any intraoperative complications.Post-op, the patient alleged unspecified injury due to use of rhbmp-2.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4265280
• MDR Text Key: 5227205
• Report Number: 1030489-2014-04469
• 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: 05/22/2017

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: 05/22/2017
• 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