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 Problem Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

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.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) 2010: patient was pre-operatively diagnosed with lumbar spinal stenosis l1-l2, 2-3, 3-4 and 4-5 with bilateral foraminal stenosis and underwent l1-2, 2-3, 3-4 and 4-5 laminectomies and bilateral micro foraminotomies and use of operative microscope for microsurgical dissection.As per the op notes:" doctor cleaned out the disk space, including the cartilaginous endplate and then packed cancellous bone into the anterior part of the disk space along with small piece of bmp, followed by further packing of the disk with bone.The bone was packed easily by using a small tamp.Once this was done, doctor cleaned out the t pieces of l1,l2,l3 and thoroughly removed the scar tissue over this area.These were decorticated and bone graft was placed over this area along with small pieces of rhbmp-2 sponge." on (b)(6) 2012: the patient was preoperatively diagnosed with multilevel degenerative disk disease and facet arthropathy, lumbar scoliosis, multilevel spinal stenosis l1-2 to l5-s1 with associated lateral recess stenosis, joint instability l1-2, l3-4, l4-5 and l5-s1.The patient underwent the following procedures: fixation, had a mayfield fixation device with pins, l1-2, l2-3, l3-4, l4-5 and l5-s1 laminectomy, excision of scar tissue, removal of more than 50% of the facet joints, l2-3 diskectomy and posterior interbody fusion l2-3, l3-4 right diskectomy and posterior lumbar interbody fusion, placement of peek cages, l1-2, l2-3, l3-4, l4-5, l5-s1 posterolateral fusion, placement of pedicle screws l1 down to the sacrum, intraoperative use of o arm and stealth navigation with placements of screws and intra-operative evoked potential monitoring and imaging monitoring.

Manufacturer Narrative

X-ray image review result: post-op ct, x-ray and intra-op images provided for long segment thoraco lumbar and the thoraco pelvic fixation.Bone quality appears poor and the reported complications of fracture at the kyphotic apex are likely a result of failure of bony fusion fracture placement on the provided images appears appropriate.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 on: (b)(6) 2012: patient underwent chest, two views.Impression: no radiographic abnormality identified.On (b)(6) 2012: patient underwent the following procedures: fixation, had a mayfield fixation device with pins.L1-2, l2-3, l3-4, l4-5 and l5-s1 laminectomy, excision of scar tissue, removal of more than 50% of the facet joints.L2-3 diskectomy and posterior interbody fusion l2-3.4.L3-4 right deiskectomy and posterior lumbar interbody fusion.Placement of polyetheretherketone cages x2.6.L1-2, l2-3, l3-4, l4-5, l5-s1 posterolateral fusion.Placement of pedicle screws l1 down to the sacrum.Intraoperative use of o arm and navigation with placements of screws.Intra operative evoked potential monitoring and imaging monitoring.Placement of left central line.As per the op notes:" soft tissue and scar tissue were dissected out of spinous process and lamina of l1-2 through l5-s1 bilaterally.Wide laminectomy was performed at l1-2, l2-3, l3-4, l4-5 and l5-s1.At l3-4, diskectomy was performed to right side by placement of peek cage, filled with bone graft to correct kyphosis.Patient underwent views of lumbar spine.On (b)(6) 2012: patient underwent lumbosacral spine 3 views.Impression: dilating of colon.These findings could represent a colonic ileus.On (b)(6) 2012: patient underwent 2 spine views.Impression: extensive posterior lumbar fusion from l1 to s1.

• 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: 6975534
• MDR Text Key: 90151535
• Report Number: 1030489-2017-02242
• 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: 12/08/2017

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: 09/26/2017
• Initial Date FDA Received: 10/25/2017
• Supplement Dates Manufacturer Received: 10/24/2017; 11/13/2017
• Supplement Dates FDA Received: 11/09/2017; 12/08/2017
• 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
• Patient Age: 59 YR
• Patient Weight: 88