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

Catalog Number 7510800

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

Patient Problems Stacking Breaths (1593); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Pain (1994); Pneumonia (2011); Tingling (2171); Stenosis (2263); Numbness (2415)

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) 2003 the patient presented with following diagnosis: idiopathic scoliosis, disc herniation l4-5, degenerative changes from l3-s1, previous fusion cotrel-dubousset instrumentation in fusion from t11-l3.The patient underwent the following operations: 1 removal of cotrel-dubousset instrumentation from t11-l3.2.Spinal concepts instrumentation from l2 to s1.3.Bilateral posterior lateral fusion from l2 to s1 with allograft cancellous bone along with bone putty.On (b)(6) 2003 the patient discharged from hospital.On (b)(6) 2011 the patient presented for an office visit due to back pain, inability to stand and walk, and urinary problems.The patient underwent examination of thoraco- lumbar spines in ap and lateral projection.Impression: scoliosis series showing marked rotoscoliosis of thoracic spine with convexity toward right side.Exaggerated kyphosis thoracic spine.Instrumentation fusion of lumbosacral spine from l2 to s1.The patient underwent mri of lumbar spine.On (b)(6) 2011 the patient presented for follow up of her back pain and inability to stand and walk.The patient underwent ct scan of the thoracic spine due to low back pain radiating to both legs.Conclusions: t11-t12: in there is nonunion of the bone graft associate the posterior elements with an appearance suggesting the presence of pseudoarthrosis with sclerosis of the margins of the graft and associated endplates; diffuse dextroscoliosis with bone grafting of the posterior elements.The patient underwent mri of thoracic lumbar spine.Impression: marked scoliosis.The mild spondylosis is l5-s1.T12-l1 spinal stenosis with focal myomalacia and mild compression of the conus.On (b)(6) 2011 the patient presented with back pain inability to stand and walk.Masculoskeletal : mild/lbp and le weakness.Neuropsychiatric: depression/anxiety.On (b)(6) 2011 the patient presented for pre-operative pulmonary clearance.On (b)(6) 2011 the patient underwent nuclear stress with gated spect and resting thallium.On (b)(6) 2011 the patient presented with following preoperative diagnosis: thoracolumbar kyphosis with nonunion and stenosis at t11 and t12.The patient underwent following operations: removal of retained hardware lumbar spine; posterior pedicle screw instrumentation at t10-t11-l2-l3-l4; posterior thoracolumbar osteotomy and lnterbody fusion, t10-t11; posterolateral arthrodesis at t10-l5; application of local autogenous bone graft and allograft bone putty t10-l5.Per -op notes: surgeon performed a subtotal discectomy and removed the cartilaginous endplates.Surgeon packed allograft bone putty and local bone graft into the disc space without difficulty.Surgeon decorticated the posterolateral elements across the affected levels, surgeon packed copious amounts of local autogenous bone graft from t10 down to l4 without difficulty.On (b)(6) 2011 the patient discharged from hospital.On (b)(6) 2011 the patient presented for follow up of posterior thoracolumbar instrumentation and fusion at from t8 to l3.On (b)(6) 2011 the patient admitted to hospital due to shortness of breath.Ct scan of chest was performed, which showed bilateral lung pneumonia.Patient discharged with following diagnosis.Bilateral hospital acquired pneumonia; chronic obstructive pulmonary disease; hypertension; spinal stenosis, scoliosis; anemia of chronic disease; anxiety depression.On (b)(6) 2011 the patient discharged from hospital.On (b)(6) 2011 the patient presented for an office visit due to pain.On (b)(6) 2011 the patient presented for follow up of her lumbar decompression and fusion.Patient complained of bilateral spasms.Patient had pneumonia.The patient underwent examination of thoraco- lumbar spines in ap.Impression: follow up scoliosis series showing revision instrumentation fusion of thoraco- lumbar spine from t11 to l4.On (b)(6) 2011 the patient presented for an office visit.Patient complained of cramping in her legs at night.Examination of the thoracic lumbar spine demonstrates marked scoliosis.On (b)(6) 2011 the patient presented for an office visit due to persistent pain and stiffness in her back.Patient underwent examination of thoraco- lumbar spines in ap and lateral projection.Impression: followup scoliosis series showing previously seen rotoscoliosis of thoracic spine with convexity toward right side and previously seen instrumentation stabilization and fusion of thoracolumbar spine from t11 to l4 unchanged since previous examination of (b)(6) 2011.On (b)(6) 2011 the patient underwent mri of lumbar spine.Impression: limited study due to extensive post-operative changes; multiple annular bulges; foramen stenosis at l4-l5.L5-si; mildly dilated extrahepatic common bile duct noted incidentally.On (b)(6) 2011 the patient presented for an office visit.Patient could stand and walk much better than before surgery.Patient had numbness and tingling to her legs.Patient underwent examination of thoraco- lumbar spines in ap and lateral projection.Impression: followup scoliosis series showing previously seen scoliosis of thoraco- lumbar spines and previously seen decompression instrumentation fusion of thoraco- lumbar spine stable and unchanged since previous examination.

• 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: 5129324
• MDR Text Key: 27526092
• Report Number: 1030489-2015-02568
• 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
• 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 Expiration Date: 07/01/2013
• Device Catalogue Number: 7510800
• Device Lot Number: M110916AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2010
• 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: 68