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

Catalog Number 7510400

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

Patient Problems Edema (1820); Seroma (2069); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on unknown date, the patient underwent mri shows evidence of a degenerative lumbar scoliosis.He has about an 18 degree curve measured from 1 down to l5.He has degenerative disk disease with disc dehydration and loss of disk height at l1-2, l2-3, l3-4, l4-5 and l5-s1.He has significant stenosis at l2-3, l3-4 and l4-5.He has foraminal narrowing at multiple levels but mainly on the right side.Impression: from a clinical point of view, his pain seems to radiate into an l4 nerve root distribution.The weakness in his tibial anterior may have an l4 component to it but there also may be an l5 component to it.However, his pain really does not radiate in the l5 distribution.(b)(6) 2011: the patient was pre-operatively diagnosed with: l2-3, l3-4, l4-5 central spinal stenosis.Left l5-s1 lateral recess and foraminal stenosis.Lumbar degenerative scoliosis and underwent.L2,l3 ,l4 and l5 complete laminectomies with bilateral s1 superior laminectomies.Left l4-5 and l5-s1 medial facetectomies performed utilizing the operating microscope and microdissection technique.Open reduction of degenerative lumbar scoliosis.L2 through s1 posterolateral onlay fusion utilizing autograft bone, allograft bone and bone morphogenetic bone( l2-3, l3-4, l4-5, and l5-s1 posterolateral onlay fusion).L2 to s1 internal fixation utilizing pedicle screws and rods with pedicle fixation at l2, l3, l4, l5 and s1.As per the op notes: ¿ pedicle screws were then placed at all of these levels.At s1, the 7.5 mm diameter by 45 mm length screws were placed.From l3to l5 the 6.5 mm diameter screws were placed that were either 50 mm in length or 55 mm in length , depending upon the bony anatomy.Thus screws were placed bilaterally at l2,3,4,5 and s1 for a total of 10 screws.Once these screws were in place, the pedicles were palpated with the murphy ball and were found to be intact.Rods were chosen to connect the pedicle screws on either side.The 12 cm length rods were used bilaterally.The rods were provisionally seated into the screws bilaterally.Once good spinal configuration has been confirmed, the set screws were broken off so that the spine was held in its spine reduced position with the screw-rod construct a posterolateral onlay fusion was then carried out bilaterally from l2 through s1 inclusive utilizing a combination of bone morphogenetic protein soaked in collagen sponge carrier autograft bone and cancellous autograft bone.¿ the patient tolerated the procedure without any intraoperative complications.(b)(6) 2011: the patient underwent x-ray examination of lumbar spine 3 views.Impression: lumbar spondylosis.Postoperative changes involving the lumbar spine.The patient underwent mri of the lumbar spine with and without iv contrast.Findings: there has been recent spinal fusion from the l2 through s1 levels.There is susceptibility artifact from the spinal fusion devices.Postoperative changes including tissue edema and small seromas are noted along the course of the surgical sites.This is however, no evidence of rim-enhancing region to suggest abscess formation.No abnormal enhancement is seen within the thecal sac.(b)(6) 2011: the patient was pre-operatively diagnosed with lumbar wound drainage and underwent lumbar wound washout.Findings: large fluid collection, nondorous, 2 cultures sent.(b)(6) 2011: the [patient underwent lumbar spine, ap and lateral.Impression: stable postop appearance.(b)(6) 2011: the patient underwent mri of the lumbar spine before and after iv contrast.Impressions: limited exam with no evidences of abnormal enhancement to suggest the presence of residual or recurrent inflammatory process.(b)(6) 2011: the patient underwent lumbar spine: ap and lateral views.Impressions: stable post-op appearance.Degenerative disc disease, stable.(b)(6) 2012: the patient underwent lumbar spine: ap and lateral views.Impressions: good postoperative appearance.Degenerative disc disease l1 stable (b)(6) 2017: the patient underwent lumbar mri.Impression: interval surgery with alleviation of spinal stenosis as described.Levels above the fusion demonstrate degenerative change without spinal stenosis.

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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7717657
• MDR Text Key: 114942149
• Report Number: 1030489-2018-01049
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843805
• UDI-Public: 00681490843805
• Combination Product (y/n): N
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2013
• Device Catalogue Number: 7510400
• Device Lot Number: M111057AAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2011
• 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