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

Catalog Number 7510600

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

Patient Problems Stenosis (2263); No Code Available (3191)

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) 2015: pre-op diagnosis: fix sagittal imbalance-status post multiple laminectomy and fusions.Procedure: exploration of posterior spinal fusion confirming solid fusion from l2 to l4.Removal of posterior instrumentation.Transforaminal lumbar interbody fusion l2-3 ,l4-5 and l5-s1.Application of biochemical intervertebral devices with titanium cages l2-3 and l4-5.Posterior segmental instrumentation t4 to s1 with a 5.5 rod.Iliopelvic fixation using solar s2 alar iliac screws.Bilateral extracavitary approach for l3 pedicle subtraction osteotomy.Revision laminectomy l2 to l5 with foraminotomies at all those levels.Harvesting local auto graft through the same incision.Posterolateral fusion t4 to l2 with local auto graft, allograft and bmp.Per-op notes: at l5-s1, segment was very stiff, posterior facets were not fused.But surgeon think that it was fused anteriorly as surgeon could really not get that space to open up, surgeon did an interbody fusion there using more cancellous bone graft and 2mg of bmp.At l4-5 standard interbody fusion was performed.The disk opened up well, a large cage was placed anteriorly.Four milligrams total in the space followed by local autograft.After screw placement, interbody fusions were accomplished at l4 and l5.Intraoperative x-ray showed to be tipped over to the left so compression on right side was done and pelvis was pulled out proximally.Surgeon decorticated all the facet joints and applied bmp divided up on bone graft, freed facet joints, followed by local auto graft as well as allograft.On (b)(6) 2015: patient was discharged today.Final primary diagnosis: status post t5-s2 instrumented posterior spinal fusion with l3 pedicle subtraction osteotomy, l2-s1 laminectomy and tlif at l2-3, l4-5 and l5-s1.Additional diagnosis: fixed sagittal imbalance status post surgery.Spinal stenosis.Lumbar compression fractures with back and leg pain.

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 on (b)(6) 2015, the patient presented with the following pre-op diagnosis: fix sagittal imbalance--status post multiple laminectomy and fusions (performed elsewhere).The patient underwent the following procedures: exploration of posterior spinal fusion confirming solid fusion from l2 to l4; removal of posterior instrumentation; transforaminal lumbar interbody fusion l2-3, l4-5, l5-s1; application of biomechanical intervertebral devices with titanium cages l2-3 and l4-5; posterior segmental instrumentation t4 to s1 with instrumentation system and a 5.5 rod; iliopelvic fixation using solera s2 alar iliac screws; bilateral extracavitary approach for l3 pedicle subtraction osteotomy; revision laminectomy l2 to l5 with foraminotomies at all those levels; harvesting local autograft through the same incision; posterolateral fusion t4 to l2 with local autograft, allograft, and rhbmp-2.As per op-notes, ¿they removed all of the soft tissue from the spine exposing the previous fusion mass and cleaned everything up really well.Then, tediously worked to get a revision laminectomy l2 down to l5 and on the left side at l4-5 for their interbody fusion at that segment.Surgeon tried for a transforaminal interbody fusion there, but clearly they would not be able to fit an actual spacer, so they did an interbody fusion using more cancellous bone graft and 2 mg of rhbmp-2.At l4-5, they did a standard interbody fusion cleaning that out.Being satisfied with their screw placement, they did the interbody fusions at l4 and l5, and once those were accomplished, performed the o-arm spin and checked everything.Therefore, they took down the fusion mass at l2-3 to underneath the l2 pedicle, down to the top of the l4 pedicle, removing all of the posterior elements, doing a revision laminectomy there.Then, decancellated the l3 superior vertebral body for a pedicle subtraction, removed the pedicles, and then extended this up for an extended pso up into the disk space so they could do a fusion directly from l2 inferior end plate down to the l3 body.In the cage at the disk space, we had applied 4 mg of rhbmp-2 as well as local autograft within that, too.They had irrigated multiple times throughout the procedure, they decorticated all the facet joints, etc, and applied rhbmp-2 divided up on graft, freed the facet joints, followed by local autograft as well as allograft.¿ 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5699984
• MDR Text Key: 46562796
• Report Number: 1030489-2016-01629
• 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: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Catalogue Number: 7510600
• Device Lot Number: M111401AAG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2014
• 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 Weight: 66