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 Neuropathy (1983); Pain (1994); Weakness (2145); Discomfort (2330); Numbness (2415); Shaking/Tremors (2515)

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 (b)(6) 2006, patient presented for ap and lateral intraoperative films of the lumbar spine.Findings: posterior fusion and screws at l4-l5 and l5-s1 with near anatomic alignment.On (b)(6) 2006 preoperative diagnosis: lumbar degenerative disk disease at l4-5 and l5-s1.Patient underwent the follow surgeries: l4-5 complete diskectomy.L5-s1 complete diskectomy.Use of fluoroscopy.L4 to s1 bilateral instrumented fusion utilizing alphatec pedicle screw system.L4 through s1 bilateral arthrodesis.Right l4-5 and l5-s1 complete facetectomy.Right l4-5 and l5-s1 foraminotomies.Use of alphatec interbody graft at l4-5, 14 x 25 mm.Use of alphatec peak structural interbody graft at l5-s1, 14 x 25mm.Use of morselized autograft.Use of morselized allograft and rhbmp-2.Op note: the correct size was found to be 14 x 25, morselized autograft was then placed out laterally in the disk space and then a 14 x 25 mm graft filled with bmp and morselized autograft was placed under fluoroscopic guidance in the middle of the body toward the anterior midline towards the anterior portion of the body.Once this was appreciated in the correct position, the next level above l4-5 was done in exactly the same way actually with a 14 x 25 mm graft placed in that space also.One this was done, radiographic and fluoroscopy showed that the grafts were in place, 7.5 mm x 50 mm pedicle screws were placed in l4, l5 and the sacrum bilaterally.Radiographs insured good placement of the pedicle screws and the rods were measured and placed and final tightening was done to insure they were in good position.Final fluoroscopic picture was once again taken and the area was copiously irrigated with antibiotic solution.Arthrodesis of the facet joints and the lateral masses were performed with a midas rex drill and morselized autograft and allograft were placed along the facet joints and laterally on the left side.Once this was done, the area was once again copiously irrigated and incision was closed with 1-0 vicryl suture in the fascial layer followed by 2-0 vicryl suture in the subcutaneous layer.A subcutaneous 7.5 jackson pratt drain was placed in the left and brought out through a separate stab incision.The skin was closed with steri-strips, and the patient was placed back in his bed in supine position.The sponge, needle and instrument counts were correct at the end of the case, and the patient tolerated the procedure well.On (b)(6) 2006, patient presented for lumbosacral spine frontal and lateral views.Findings: posterior pedicle screws are present at the levels of l4, l5 and s1, with stabilizing rods extending from l4 to s1.The intervertebral disc space plugs with metallic markers are present at the l4-l5 and l5-s1 levels.There is no spondylolisthesis.Vertebral bodies are normal in height.Intervertebral disc spaces were normal.There was no focal bony abnormality.Impression: post-operative changes with rods and screws as described above.No significant abnormality.On (b)(6) 2006, patient was discharged from the hospital.On (b)(6) 2006, patient was presented for neurosurgical follow-up post an l4-s1 transforaminal lumbar interbody fusion.On (b)(6) 2006, patient was presented for neurosurgical follow-up.Patient continued to have some low back pain and some radiation down to his right lower extremity he stated that the right lower extremity discomfort was intermittent but it was still there.He continued to wear his brace and his incision was well healed.On (b)(6) 2007, patient was presented for neurosurgical follow-up.Patient continued pain and numbness in both of his feet and weakness in his legs.The patient had flexion/extension x-rays of his lumbar spine which did not demonstrate malalignment.He complained of severe low back pain with radiation down to his right lower extremity and new onset of right leg tremor which he described as constant.The patient says that he cannot stop this tremor.He also complains of some calf tightness.On (b)(6) 2007, patient was presented for neurosurgical follow-up.Patient continued to have some numbness and tingling in the bottom of his foot on the right side and some twitching in his bilateral lower eternities.He continued to have severe back spasm in his lumbar region and this has not been improving.On (b)(6) 2007, patient was presented for neurosurgical follow-up.Patient continued to have excruciating low back pain, with radiation down his legs.He still had some shaking of his legs that has been unexplained neurologically.Musculoskeletal: on physical examination, he has a lot of low back spasms, but he also has some tenderness over his bilateral si joints.He had pain radiating across his ileum bilaterally and into his groin and down his anterior thigh.He also had some pinpoint discomfort right over his greater trochanter bilaterally.

• 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
• 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: 5179497
• MDR Text Key: 29404915
• Report Number: 1030489-2015-02806
• 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: M115006AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 10/27/2015
• 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