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

Catalog Number 7510200

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

Patient Problems Stenosis (2263); Ambulation Difficulties (2544); No Code Available (3191)

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) 2013, the patient underwent a spinal fusion surgery on the lumbar region of his spine from vertebrae l4 to l5.Reportedly, during the surgery, rhbmp-2/acs was used in the patient.It was also reported that the rhbmp-2 collagen sponge was placed outside a cage (i.E.In the disc space).As reported, the patient's post-operative period had been marked by a period of improvement, followed by a progressive return of back and leg pain.Severe pain and symptoms ultimately compelled patient to undergo a second revision surgery on (b)(6) 2015.Unfortunately, despite two revision surgeries, patient continues to experience chronic and extreme low back pain, with pain radiating down her right leg, numbness in her legs and toes, and bladder and bowel issues.Patient has reduced mobility, experiences difficulty walking, and requires use of a cane when walking extended distances or in times of extreme pain.These serious injuries prevent patient from practicing and enjoying the activities of daily life that patient enjoyed pre-operatively.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2013: the patient was pre-operatively diagnosed with status post previous lumbar surgery with an l5-s1 lumbar fusion.L4-l5 spondylolisthesis.Lumbar stenosis, recurrent and underwent the following procedure: exploration of spinal fusion.Removal of posterior pedicle screw instrumentation, l5-s1.Revision lumbar laminectomy, bilateral facetectomy and bilateral foraminotomy l4-l5.Repair of csf leak/dural tear within the scar tissue.Posterior pedicle screw instrumentation using the titanium screw system l4, l5, s1.Posterior lumbar interbody fusion using tlif fusion at l4-l5.Use of local bone graft augmented with rhbmp-2 allograft material for purposes of fusion.Insertion of intervertebral biomechanical cage device using the luminary system, size 10.As per op-notes, trials were used and size 10 trial appeared to fit best.At this stage, local morselized bone graft straight from the spinous process was packed into the disc space and this was followed by a small rhbmp-2 allograft sponge.The rhbmp-2 was placed and then on top of this a 10 mm prepacked luminary size 10 cage was impacted and then covered with also additional rhbmp-2 and local morselized bone graft at l4-l5.The patient tolerated the procedure well and no complications were reported.On (b)(6) 2014: the patient underwent ct of lumbar spine with intrathecal contrast due to back pain.Impressions: incomplete fusion at l4-l5 with a horizontal lucency through the disc space.Lucency is seen around the pedicle screws at l4, suggesting loosening.A curvilinear lucency is identified at the posterior right aspect of the l4 vertebral body suggesting a possible fracture.Foraminal stenosis is seen most pronounced on the right at l3-l4 and on the right at l4-l5.Moderate foraminal stenosis is also seen on the left at l3-l4 and on the left at l5-s1.On (b)(6) 2015: the patient was pre-operatively diagnosed with status post previous lumbar fusion with a posterior laminectomy, kyphosis and possible non union and underwent exploration of spine fusion.Post-operative diagnosis: post laminectomy kyphosis, however, with a healed fusion including the kyphotic segment with no evidence of hardware failure.

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.

• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5543553
• MDR Text Key: 41721191
• Report Number: 1030489-2016-00892
• 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,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Catalogue Number: 7510200
• Device Lot Number: M111302AAQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/09/2013
• 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