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 Pain (1994); Ulcer (2274); Sleep Dysfunction (2517)

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.

Event Description

It was reported that (b)(6) 2008 patient presented with ddd, spondylosis, stenosis, multilevel radiculopathy, failure of conservative treatment.Procedures: l2 to sacral pedicle screw stabilization, "decompressive lami," complete l3-4, l4-5, l5 and partial s1, foraminotomies at l3-4, l4-5 and l5-s1 bilaterally, transforaminal posterior lumbar interbody fusion l3-4, l4-5 and l5-s1, dural repair to the left l4-5, neurolysis of l4, l5 and s1 roots bilaterally, transpedicular marrow aspiration x3, application of vitagel and posterior bone graft.Patient presented for ct lumbar spine.On (b)(6) 2008 patient presented due to preoperative diagnoses: multilevel lumbar degenerative disc disease.Spinal stenosis.Multilevel radiculopathy.Lumbar spondylosis.Failure of conservative treatment.Patient underwent the following procedures: l2 to sacral pedicle screw stabilization with zimmer dynesys instrumentation.Decompressive laminectomy, complete l3, l4, l5, and partial s1.Foraminotomies, l3-4, l4-5, and l5-s1, bilaterally.Transforaminal posterior lumbar interbody fusion, l3-4, l4-5, and l5-s1, using peek interbody cage, reconstruction and rhbmp-2/acs, as well as lntergro dbx.Dural repair left l4-5.Neurolysis, l4, l5, and s1 roots, bilaterally.Transpedicular bone marrow aspiration times three.Application of vitagel.Posterolateral bone graft, combination of locally harvested autograft, vitoss, beta tricalcium phosphate, plus bone marrow aspiration and rhbmp-2/acs or bone morphogenic protein.Op note: a 6-mm tap was used to tap the tract into the vertebral body, and the tract palpated with a ball-tipped probe for good circumferential bone.No medial or lateral pedicle breech, and a good bony bottom, and 7-mm x 50-mm screws placed bilaterally at l5.The inferior facet of l5 was then removed, creating an oblique cut through the lamina and pars to expose the s1 pedicle.The s1 foramen was located and, using the stryker tps bur, a tract created bilaterally into the s1 pedicle and the pedicle finder used to cannulate the s1 pedicle.To contact the anterior portion of the sacrum without penetration of the bone anteriorly.A 6-mm and then 7-mm tap were used to tap the tract into s1, and bilateral 8-mm x 4 s5-mm.Pedicle screws placed in s1, the l5 transverse process was decorticated as well as the sacral ala.Attention was directed more proximally to l2 where bilateral pedicle screws were placed with similar technique at l2, placing 6.2-mm x 50-mm screws at l2, 7-mm x 50-mm screws at l3, and 7-mm x 45-mm screws at l4.The l3 and l4 transverse processes were decorticated bilaterally, and hemostasis achieved in the posterolateral gutter with surgiflo temporarily.Attention was directed "tci" the decompression portion of the procedure where the inferior portion of the l3 spinous processes was resected.The complete l4, l5 and superior portion of the s1 spinous process were completely resected and morselized and placed on a back table for bone graft.The stryker tps bur was used to create a trough cut down the lamina-facet joint junction bilaterally to lift off the entire posterior elements of the spinal canal in one piece, removing the l4, l5 lamina and again, the superior portion of the s1 lamina in the inferior portion of l3.Pedicle to pedicle decompression was completed with a #s kerrison rongeur and on the right side, annulotomies performed retracting the dura medially and visualizing the l3 and l4 root directly and accessing the l3-4 disc.A disc shaver was placed into the disc space sequentially to remove as much of the herniated nucleus pulposus and annulus as possible and the endplates decorticated to bleeding bone.A standard trialling was then performed; trialling the disc space for interbody graft selection, and an 11-mm graft, a banana-type peek cage was selected, packed with rhbmp-2/acs and impacted into place into the midline and as anterior in the disc space to just posterior to the anterior longitudinal ligament as possible.A similar discectomy and interbody grafting was performed at l4-5 and l5-s1 utilizing a 9-mm graft or peek cage with bone morphogenic protein at l4-5 and a 9-mm cage at l5-s1, all placed again via right-sided annulotomies.Attention was then directed again to neurolysis of the extremely scarred l4, l5 and s1 roots which were completely neurolysed and mobilized bilaterally, and complete foraminotomies achieved at l4-5, l5-s1, and l3-4 to the transverse foraminal ligaments.The entire wound was copiously irrigated with antibiotic-impregnated saline via the pulsatile syringe, and the posterolateral gutters packed with a combination of locally morselized autograft, vitoss, and the beta tricalcium phosphate which was obtained via the transpedicular aspirations at l3, l4 and l5 and the rhbmp-2/acs.The exposed dura was covered with a layer of surgicel, avitene and vitagel for hemostasis.It should be noted that in removing the l4 and l5 lamina, there was extreme adherence of the ligamentum flavum and tissue to the dura and an arachnoid bleb was created, and a dural repair performed with three 4-0 nurolon sutures creating a watertight dural repair on the left at l4-5 prior to placing the surgicel and avitene.Two deep subfascial hemovac drains were placed, overlying the exposed dura and secured to the skin with a 3-0 nylon suture.There were no intraoperative complications.No sustained emo, ssep, or mep el ectrodiagnostic changes throughout the procedure.On (b)(6) 2008 patient was examined about the three millimeter axial images of the lumbar spine from t12 to s1 with sagittal and coronal reformatted images.No contrast was administered.On (b)(6) 2008 patient underwent due to back pain and excruciating - 19 right leg pain versus the left.On (b)(6) 2008 patient got discharged from hospital.On (b)(6) 2009 patient presented to office for follow-up due to complaint of left shoulder pain, especially with elevation and abduction.He had trouble sleeping on his shoulder.He had severe crepitation with rom and was told that he had severe degeneration of his ac joint and possibly some rotator cuff problems.He had prior right shoulder surgery.He had a normal rom of his right shoulder.His left shoulder was not limited with regard to adduction and external rotation.He does have a positive supraspinatus stress test, pain with cross-body abduction and didn't palpation of his adjoin.Crepitation with impingement sign.He had a negative lift-off sign.On (b)(6) 2009 patient presented to office for follow-up due to plain x-rays of the lumbar spine obtained.On (b)(6) 2009 patient presented for x-rays.Radiographs: x-rays show instrumentation from l2 to s1.At 2-3 he must have a flexible rod which was radiolucent.He had a solid rod from l3 to s1.He had interbody cages at 3-4.4-5 and 5-1.There was no hardware failure or other malalignment.Impression: chronic pain syndrome.Multilevel lumbar fusion.Patient presented with high bp, ulcer.

• 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: 5178025
• MDR Text Key: 29314785
• Report Number: 1030489-2015-02798
• 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: 09/28/2015

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 Catalogue Number: 7510400
• Device Lot Number: M110801MD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 10/26/2015
• 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 Weight: 80