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 Angina (1710); Cyst(s) (1800); Neuropathy (1983); Vomiting (2144); Stenosis (2263)

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.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) 2001, the patient presented with pre-op diagnosis of degenerating disk at l3-4.Chronic low back pain, left greater than right, with lower extremity pain.Patient underwent following operating procedure: decompressive laminectomy, l3-4.Posterior lumbar interbody fusion, allograft bone dowel fusion, l3-4.Supplemental autograft interbody fusion, l3-4.Pedicle screw instrumentation, multiaxial screws, l3-4.Per op note, ¿surgeon then proceeded to tap a 12 mm x 20 mm allograft bone dowel into place with good purchase.Once this was accomplished, the distractor on the opposite side was removed and a similar procedure was carried out.Prior to placement of our second allograft bone dowel, surgeon did take autograft bone taken from our decompressive laminectomy site and placed this down medially, as well as laterally.The second bone dowel was then tapped into place with good purchase.At this point i felt surgeon could not improve upon our arthrodesis.We then turned our attention to identifying the pedicles at l3 and l4 and we proceeded to decorticate the pedicle with a 3 mm side cutting bur and then 6.5 x 55 mm screws were placed in all four pedicles.Prior to their placement surgeon did sound the pedicle out with the ball-tipped probe and there was no evidence of any penetration of the pedicle.Surgeon identified the nerve roots and they were clear bilaterally.The screws were placed with excellent purchase and surgeon obtained an intraoperative scout film which showed good placement of the screws within the vertebral bodies.An approximately 3.5 cm titaniu m rod was then placed in the top heads of the screws.Prior to their final tightening, surgeon did compress the interspace.Once this was accomplished, a cross link was applied and then surgeon proceeded to irrigate copiously.On (b)(6) 2006, the patient presented with pre-op diagnosis of status post previous decompressive lumbar laminectomy, fusion l3-l4.Adjacent level stenosis l4-l5 subluxation.Spondylolisthesis l4-l5.Recurrent low back pain.Bilateral lower extremity pain.The patient underwent following procedure: 1)re-opening of previous laminectomy site l3-l4.Takedown of fusion.Extension laminectomy l4-l5.Posterior lumbar inter body fusion l4-l5.Peek interbody fusion.6) supplemental bone morphogenic protein autograft.Re-instrumentation l3 to l5.Pedicle screws.Per op notes, ¿.Carefully mobilized the scar over the previous instrumentation at l3-l4, isolated the screws and rod, and extended our incision to include the l4-l5 interspace as well.Then surgeon proceeded to take down the rod at l3-l4.Later surgeon placed 10-mm x 22-mm grafts within the interspace of l4 and l5, supplementing this with bmp as well as autograft taken from the laminectomy site.After this they placed 6.5 x 45-mm screws within the pedicles of l5.Once this was accomplished, surgeon extended the rod lengthening this to 7 cm with a lordotic curve.Final tightening was accomplished at the l4-l5 interspace.¿ on (b)(6) 2009, the patient presented with pre-op diagnosis of left l5-s1 foraminal stenosis.Synovial cyst.Low back pain.Left l5 radiculopathy.Failure of conservative therapy.The patient underwent following procedure: left l5-s1 hemilaminectomy.Foraminotomy.Resection of synovial cyst.On (b)(6) 2009, the patient presented for office visit.On (b)(6) 2010, the patient presented with pre-op diagnosis of unstable angina and underwent following procedure: selective bilateral coronary angiography.Left heart catheterization.Left ventriculogram.Angio-seal placement to the right femoral artery.On (b)(6) 2010, the patient presented with pre-op diagnosis of epigastric abdominal pain, nausea, vomiting and hematemesis and underwent esophagogastroduodenoscopy with biopsies of the stomach, duodenum and esophagus.

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5349498
• MDR Text Key: 35214495
• Report Number: 1030489-2016-00070
• 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
• Report Date: 12/14/2015

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
• Device Expiration Date: 10/30/2007
• Device Catalogue Number: 7510200
• Device Lot Number: M114006AAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 01/07/2016
• 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