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 Ossification (1428); Incontinence (1928); Neuropathy (1983); Swelling (2091); Weakness (2145); Stenosis (2263); Numbness (2415); Ambulation Difficulties (2544)

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) 2010 the patient underwent anterior interbody fusion surgery on the lumbar region of his spine from vertebrae l3 to s1 using rhbmp-2 and collagen sponge which was used to fuse more than one level of the spine.Post-op complications: progressive worsening and chronic low back pain with pain and radiculopathy into his left leg and down to his left foot, weakness and decreased sensation in his left leg, numbness in his left leg and foot, swelling in his left leg, paralysis of his little toe, urinary issues, and difficulty walking, sitting, and standing for extended periods.Reportedly the patient underwent decompressive revision surgery due to severe pain and worsening symptoms.Operative findings included an overgrown l5 facet pushing in to the l5 nerve root, causing significant stenosis in the foramen at l5, and inflammation of the nerve.These serious injuries prevent patient from practicing and enjoying the activities of daily life.

Event Description

It was reported that on: (b)(6) 2010: the patient was preoperatively diagnosed with lumbar scoliosis.Multilevel lumbar spinal stenosis and underwent the following procedures: l3-l4 anterior lumbar diskectomy for decompression of nerve roots and restoration of alignment.L4-l5 a nterior lumbar interbody diskectomy and restoration of disk height.L5-s1 anterior lumbar diskectomy and restoration of disk height.Placement of synfix anterior vertebral biomechanical device at l3-l4, l4-l5 and l5-s1.Anterior instrumentation at l3-l4, l4-l5 and l5-s1 using the synfix device.Anterior lumber interbody arthrodesis at l3-l4, l4-l5 and l5-s1.Posteriorsegmental instrumentation at l3, l4, l5 and s1.A 0-arm image guided navigation.As per the operative notes, ¿all the posterior osteophytes were removed in order to provide more room for the grafts.A synfix trial was used to assess the correct size.A 12-degree of lordosis synfix graft was taken.It was found to be a good fit.It was filled with bone morphogenic protein, placed on bonegraft putty.It was then delivered down into the disk space using the squid delivery device.Another 12-degree lordotic synfix device was obtained.It was filled with bone morphogenic protein and bonegraft putty.It was delivered down into the disk space in a controlled delivery fashion and realigning the height.The aiming guide was attached to the anterior plate of the synfix device, and the awl was used to make pilot holes in the l4 and l5 bodies, and 20-mm screws were placed bilaterally at l4 and l5.At this point, an 8-degree lordotic device was used instead of 12.It was filled with bmp and bonegraft p utty.It was delivered down into the disk space with good restoration of height and realignment of the spine.¿.

• 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: 5382353
• MDR Text Key: 36464571
• Report Number: 1030489-2016-00218
• 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: 08/14/2017

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: 01/04/2016
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: 08/14/2017
• Supplement Dates FDA Received: 08/18/2017
• 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): Required Intervention