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 Chest Pain (1776); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Pain (1994); Tachycardia (2095); Numbness (2415); Choking (2464); Palpitations (2467)

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.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) 2012, patient presented for ct lumbar: with reconstructive images.(b)(6) 2012, patient presented to undergo functional capacity and impairment rating test.(b)(6) 2012, the patient presented for pre evaluation /examination.(b)(6) 2012 , the patient was admitted due to low back pain with injury.Per op notes , preoperative diagnosis was retained hardware l5-s1.Spondylolisthesis and foraminal stenosis l4-l5.Lumbar disc disease.Lumbar radiculopathy.Facet instability.He underwent following procedure - removal of old hardware.Posterior spinal fusion l4 to l5 with eos pedicle screws.Posterior lumbar interbody fusion, kimba cage, l4-l5.Use of local bone, allograft and grafton dbm.Decompression laminectomy, foraminotomy and partial facetectomy l4-l5.Procedure - : after making the initial incision in the midline along his old scar, the old hardware was exposed and this was removed before taking the pins out.This was tested for the fusion and this was intact.At this point, after removing the screws, the l4 transverse process was identified and the pedicle screws were placed at l4.Next, the overlying scar tissue was resected off the superior portion of the remnant and l5 lamina, as well as the inferior portion of the l4 lamina and then the lamina and the spinous process were reseated.Next, there was a fair amount of thickening of the facet complex due to the instability which required resection, as well as removal of a portion of the facet complex primarily of the l4 contribution to the l4-5 facet complex.At this point, due to the nature of the facet resection, as well as the underlying instability, the complete portion of the facet was resected exposing kambin's triangle.At this point, after placing the screws and distracting, interbody grafting was performed protecting both the exiting and traversing nerve root after aggressive decortication of the end plates, which was performed after protecting the roots, the endplates were debrided and abraded and then packed with the graft and the cage was inserted.Next, compression was applied across the construct and the wound was thoroughly irrigated and closed after packing the gutters.(b)(6) 2012, patient presented for follow up postop.Treatment of brace/cast has helped to relieve the symptom.X-rays of the lumbosacral spine were ordered, obtained and interpreted.(b)(6) 2012 , the patient presented with chief complaint of back pain and numbness.Patient is happy with his improvement in pain.(b)(6) 2012, patient presented for follow up with worsening of his groin and buttock pain.4 views of the lumbosacral spine were ordered, obtained and interpreted from an orthopedic standpoint.Impression :- aftercare following surgery on musculoskeletal system.Low back pain.Patient was also suggested to increase his physical therapy to 3 times a week.(b)(6) 2012, patient diagnosed with lumbar degenerative disc dis; lumbar post lam syndrome; w/back pain.Outpatient rehabilitation: 2x week for 4 weeks: 5 visits (b)(6) 2012 , the patient was here with symptom including chest pain, a choking or smothering sensation, dry mouth, light-headedness, palpitations, shortness of breath, and tachycardia.He complained of depression and anxiety.Assessment:- anxiety; routine physical exam; asthma; cold with influenza (b)(6) 2012, the patient presented for physical therapy.(b)(6) 2012, patient presented with essential hypertension.(b)(6) 2012, patient underwent ct lumbar spine w/o contrast.Impression : post operative changes at l4-5.No evidence of hardware failure there is some solid fusion across the disc space.Old post surgical changes at l5- s1.Mild neural foraminal narrowing at l5-s1 on the right.(b)(6) 2012, patient presented for follow up of back pain/numbness.He also wants to know result of his ct myelogram.His surgery was a year old.Impression :- neuritis/radi thor/lumbar, low back pain, post lami syndrome lumbar, 722.52 degenerative lumbar disc chron.Physical therapy has helped to relieve the symptoms.(b)(6) 2013, patient underwent functional ability analysis.(b)(6) 2013 , patient came for lab result follow up.(b)(6) 2013 , patient presented with stiffness and numbness along with back pain.X-rays of the lumbosacral spine were ordered.Impression -:lumbar degenerative disc disease ; lumbar post lam syndrome; low back pain; neuritis/radi thor / lumbar.Ap/lateral radiographs of the lumbar spine reveal the hardware to be in position.No lucencies are noted.On examination, he walks with a short-stepped gait and without balance disturbance.There is a well-healed surgical scar at the back.There is no cervical lymphadenopathy.(b)(6) 2013, patient presented with mixed hyperlipidemia.Patient underwent lab tests including total cholesterol level ( 205 mg/di ), triglycerides ( 121 mg/di), hdl ( 45 mg/dl ), and ldl cholesterol ( 136 mg/di on (b)(6) 2013 ).Assessment:- mixed hyperlipidemia; essential hypertension (b)(6) 2013, (b)(6) 2014, patient presented with acute sinusitis.Primary symptoms include facial pressure, fatigue, nasal congestion, post-nasal drip and rhinorrhea.(b)(6) 13; (b)(6) 2014, patient presented for follow up visit and stated that his pain continues in his back and radiates.He underwent physical examinations and refilled for medicine.(b)(6) 2014, patient presented with right earache and tender, marked lymph node enlargement and possible infection.He was examined and medical history was reviewed.Assessment - acute sinusitis, lymphadenopathy, temporomandibular joint disorder.Impression: lumbar post lam syndrome; low back pain.

• 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: 5073650
• MDR Text Key: 25623936
• Report Number: 1030489-2015-02323
• 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: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2014
• Device Catalogue Number: 7510200
• Device Lot Number: M111101AAI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2011
• 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
• Patient Weight: 90