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

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

Patient Problems Neuropathy (1983); Hernia (2240); Stenosis (2263); Injury (2348); Arachnoiditis, Spinal (2390); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)94).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) 2004: the patient went for an office visit due to hip condition for follow up.Per the medical records.Impression: 1) back pain.2) lumbar radiculopathy.On (b)(6) 2004: the patient underwent lumbar laminectomy with partial facetectomy.Preop: lumbar radiculopathy with discogenic pain.Procedure: 1) decompressive lumbar laminectomy with partial facetectomy and foraminotomy at l4-s1.2) posterolateral fusion with instrumentation at l4-s1 using spinetek st-360 pedicle screws.3) percutaneous aspiration left iliac crest with harvesting and transplanting of stem cells with vitoss cancellous bone substitute.4) local autograft.Perop: a midline longitudinal incision was made over the lower back centered between l4 and $1.It was carried down through the skin, deep fascia, and paras pinal musculature.A laminectomy was performed at l4 and 51 followed by partial facetectomies and a foraminotomies spinetek st-360 pedicle screws were placed in the pedicles of l4 through s1.Bilaterally, each screw was stimulated using electromyogram stimulation.A bone biopsy needle was placed percutaneously to the iliac crest, harvesting and transplanting stem cells with vitoss cancellous bone substitute.This together with local cancellous autograft was packed in the lateral gutters between l4 and s1, accomplishing the fusion.Quarter-inch rods were connected to the pedicle screws.On (b)(6) 2005: the patient underwent anterior lumbar interbody fusion with instrumentation at l4-s 1.Preop diagnosis: lumbar radiculopathy with discogenic pain and failed hardware.Procedure: 1) anterior lumbar interbody fusion with instrumentation at l4-s1 using spinetech bax lordotic cages.2) rhbmp-2/acs bone morphogenic protein.3) exploration of fusion.4) bone marrow aspiration of l4 vertebral body with harvesting and transplanting of stem cell with vitox can cancellous bone substitute.5) intraoperative fluoroscopy.6) ssep and electromyographic nerve conduction study monitoring.Perop: a 6.0 centimeter longitudinal incision was made over me lower abdomen centered below the umbilicus, centered between l4 and s1 and carried down through the anterior and posterior rectus sheath.Two 15 x 20 millimeter lordotic bak cages were threaded into place at the ls-s1 level, at l4-l5 because of difficulty in access, subsequently only one midline cage would be able to be performed and this was a 17 x 24 millimeter cage.A bone marrow aspiration needle was placed through the body of l4, aspirating bone marrow which was harvested and transplanted for stem cells with vitox, cancellous bone substitute; this together with infused bone morphogenic protein was used to fill the cages, copious irrigation was performed prior to placement of the bone morphogenic protein.On (b)(6) 2006: the patient underwent ct lumbar spine without contrast.Impression: postoperative lumbosacral spine with multi-level spondylosis.No central stenosis or neural foraminal narrowing was seen.On (b)(6) 2006: the patient went for an office visit for follow up due to low back pain.Lumbar spine: x-rays from 8-7-06 were reviewed.The x-rays demonstrate posterior instrumentation at l4-l5 and l5-s1.The pedicle screw at s1 is fractured.She has two cages at the l5-s1 level and one at the l4-l5 level.On (b)(6) 2006: the patient underwent mri of the lumbar spine with gadolinium.Impressions: no evidence of stenosis posterior to the sites of fusion and laminectomy there is mild stenosis of l2-3 and l3-4.Primarily secondary to bilateral facette degeneration and ligamentum flavum hypertrophy at these levels.On (b)(6) 2007: the patient went for an office visit for follow up.Lumbar spine: x-rays reveal the screws and cage in good position.There is slight l3-4 anterolisthesis.On (b)(6) 2007: the patient went for an office visit for follow up.Per the medical records: lumbar spine: x-rays reveal the screws and cage in the same position.There is a slight l3-l4 anterolisthesis.The previous fusion looks healed at this point.On (b)(6) 2007: the patient went for an office visit for follow up.Per the medical records: lumbar spine: x-rays reveal the screws and cage in the same position.There is a slight l3-l4 anterolisthesis.The broken s1 screw is known.On (b)(6) 2007: the patient went for an office visit due to discogenic pain.Per the medical records.Impression: lumbar radiculopathy with disco genic pain.On (b)(6) 2007: the patient went for an office visit for follow up of neck pain with radiculopathy as well as left shoulder pain.Per the medical records.Impression: 1) cervical radiculopathy.2) cervical discogenic pain.3) left shoulder tendinitis, possible rotator cuff tear.Xray findings show that: there is a midline c4-5 herniation per the radiologist.On (b)(6) 2007: the patient went for an office visit for follow up.X ray findings shows problem at l3-4.

• 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: 5041572
• MDR Text Key: 24523612
• Report Number: 1030489-2015-02112
• 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: Other
• Report Date: 08/03/2015

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2015
• 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): Required Intervention
• Patient Weight: 82