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

Catalog Number 7510400

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

Patient Problems Ossification (1428); Pain (1994); Stenosis (2263); Discomfort (2330); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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) 2004 the patient underwent the following surgeries performed: 1.Complete anterior discectomy, l3/4, 2.Anterior interbody cage fusion, l3-l4 with bilateral tfc ray cages, 3.Application of bmp bilaterally, l3/4, cages, 4.Pathfinder posterior segmental instrumented fusion with bilateral screws and rods, l3/4 to treat the following pre-op diagnosis: 1.Degenerative disk disease, lumbar spine, 2.Intractable back pain.Op-notes: the posterior annulus was stripped.Entire discectomy took place.Curets were used to prep the end plates and get down to bleeding bone along the inferior portion of l3 and the superior portion of l4.Adequate positon was obtained for application of 16mm ray tfc cages.Unit tangs were inserted into the disk space after marking level in midline.The tangs were tamped into place.Once into a good position they sequentially went through drilling and tapping.This was done under direct fluoroscopic interpretation.Once this was complete the entire disk space was reinspected.Minimal amounts of loose remaining disk material were removed.A 16mm unite tang cages were then inserted 16mm bilaterally into the l3/l4 interspace.They were placed at the appropriate depth.Once this was complete the tang was removed.The entire area was inspected and was found to be free from injury.Pre-prepped bmp medium kit was then inserted into the cages at l3/4.Final x-rays in the ap and lateral planes showed excellent placement of hardware.The patient underwent successful extubation and transferred to the recovery room.Reportedly, the patient's post-op period has been marked by severe pain and discomfort in his lower back and lower extremities.Reportedly, on (b)(6) 2007, patient underwent a revision procedure to relieve severe stenosis at his original rhbmp-2/collagen sponge surgical site.Reportedly, on (b)(6) 2009 the patient underwent a l3 to s1 spinal fusion surgery to relieve foraminal stenosis in the lumbar region of his spine.Reportedly, a significant amount of bone was removed to free the nerve roots.Reportedly, the patient continues to experience severe and unrelenting pain in his lumbar spine.He suffers from severe intractable buttock and bilateral lower extremity pain, with accompanying numbness.

• 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: 5328666
• MDR Text Key: 34387776
• Report Number: 1030489-2015-03576
• 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: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510400
• Device Lot Number: M112003ABB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2015
• 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