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

Catalog Number 7510100

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

Patient Problems Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tingling (2171); Stenosis (2263); Numbness (2415)

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.

Event Description

It was reported that on (b)(6) 2013, the patient underwent transforaminal lumbar interbody fusion surgery from vertebrae l5 to s1.Reportedly, rhbmp-2/acs was used in this surgery.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the disc space).Post-op, the patient suffered from increasingly severe low back and left leg pain.Severe pain and symptoms ultimately compelled patient to undergo two risky, painful and costly revision surgeries, on (b)(6) 2015 and (b)(6) 2014.In (b)(6) 2015, the patient was seen for increasing pain in her back, with pain extending into her buttocks, hips, groin and lateral thighs bilaterally.She had associated numbness and tingling of the toes bilaterally.Lumbar ct revealed no evidence of solid fusion and heterotopic bone formation on the left at the l5/s1 segment with moderate to severe foraminal stenosis.Because her physician felt a redo-foraminotomy at this level would be extremely challenging and unlikely to give her any significant improvement, she was referred to pain management for consideration of a spinal cord stimulator trial.A spinal cord stimulator was implanted in (b)(6) 2015, but failed to provide significant relief.Patient underwent a third revision surgery on (b)(6) 2016.Despite three revision surgeries, patient continued to experience low back pain, pain in her right hip and leg, swelling in her back, and numbness and tingling in her right leg.She could not sit, stand or walk for extended periods and currently wears a back brace daily.Yes another revision surgery may be required.These serious injuries prevent patient from practicing and enjoying the activities of daily life.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented with following pre-op diagnosis: lumbar spondylosis; lumbar degenerative disk disease.The patient underwent following procedures: bilateral l5-s1 laminectomy with facetectomy and foraminotomy; transforaminal lumbar interbody fusion at l5-s1 with posterior lateral instrumentation.As per operative notes,¿ once the disk space was adequately prepared, i then copiously irrigated the disk space.I then placed a small amount of bmp combined with autologous bone graft into the disk space.I then took a 10 mm expandable peek cage.The cage expanded from 10 mm to 13 mm.I implanted it into the disk space.I did have to change the trajectory slightly because i saw some emg activity initially.It was not persistent.I implanted the graft into the disk space and then expanded it to its full 13 mm fully expanded position.I also did a 12 degree lordotic curve.I checked a lateral x-ray confirming adequate placement of the graft.I then filled the graft with a combination of autologous bone graft and a small amount of bmp.Once this was completed i copiously irrigated with antibiotic irrigation.¿ no intra-operative complications were reported.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5768571
• MDR Text Key: 48716256
• Report Number: 1030489-2016-01989
• 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,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: 7510100
• Device Lot Number: M111209AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2013
• 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