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); Anemia (1706); Dyspnea (1816); Fever (1858); High Blood Pressure/ Hypertension (1908); Stenosis (2263)

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 per medical records (b)(6) 2005 the patient presented with low back pain.He underwent diagnostics of lumbosacral w bend.Impression: mild degenerative spondylolisthesis, l4-l5.No evidence of vertebral instability.On (b)(6) 2006 the patient underwent an mri scan.He was diagnosed with ddd at l4-5 and spondylolisthesis.On (b)(6) 2006 the patient had x-rays done.A finding was a slip of 5mm at l4-5.On (b)(6) 2006 the patient presented with low back pain.The symptoms are aggravated by exertion, prolonged standing, walking, and work duties associated features include back stiffness, hip pain, and parenthesis in leg.Review of systems: musculoskeletal: complains of joint pain.Denies back pain, neck pain, joint swelling, muscle cramps, muscle weakness, stiffness, arthritis.Neurologic: denies transient paralysis, weakness.Paresthesias, seizures, syncope, tremors, vertigo, numbness, imbalance, incoordination, headache, visual changes, tinnitus.Psychiatric: denies depression, anxiety, memory loss, mental disturbance, suicidal ideation, hallucinations.On (b)(6) 2006 the patient was admitted due to l4-5 herniated lumbar disk with spinal stenosis and spondylolisthesis and history of hyperlipidemia.The patient underwent the following procedures: decompressive laminotomy, l4-5 with posterior lumbar interbody fusion with cages, posterolateral fusion with morsellized autologous bone and bnp and pedicle screw fixation.Also, chest x-rays x2 which were negative, v/q scan which showed low probability of a pulmonary embolism, ct of the abdomen and pelvis which did "now" show any abdominal abscess or fluid collection, and was essentially unremarkable.Procedure: fluoroscopic images were obtained to place two 12 x 26 cages at l4-5 with good alignment.Once those were in position, attention was turned to the pedicles which were then cannulated and tapped and had the pedicle screws placed: 6.5 mm x 50 mm screw placed at l4, 6.5 mm x 45 mm screw placed on the right side at l5, and 6.5 x 40 mm screw placed on the left at l5.These were then locked to the 1/4 inch rod and a central 20 mm cross-link attached.The transverse processes were then decorticated with a drill and a combination of morselized autologous patient bone was wrapped inside bmp arid then packed into the lateral gutters.The wound was then copiously irrigated with antibiotic irrigation.On (b)(6) 2006 the patient presented with shortness of breath.He underwent certain lab tests.He was assessed with shortness of breath and fever, hyperlipidemia, obesity, elevated blood pressure, anemia.On (b)(6) 2006 the patient underwent a chest diagnostic test.Impression: normal chest.On (b)(6) 2006 the patient presented with dyspnea.The patient underwent ct scan of the abdomen and pelvis with contrast.The lung bases show some posterior pleural parenchymal scarring greater in the lower left lung.The liver, spleen, pancreas and kidneys are normal.Impression: low probability for pulmonary embolism.On (b)(6) 2006 the patient was discharged with the following diagnoses: l4-5 herniated lumbar disk with spinal stenosis and spondylolisthesis, history of hyperlipidemia, fever which had resolved constipation and hypertension which is controlled and likely due to pain control.On (b)(6) 2007 the patient underwent a diagnosis of the lumbosacral bend.Impression: no instability is demonstrated.There is mild retrolisthesis of l3 on l4 in neutral, flexion and extension position.

• 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: 5090485
• MDR Text Key: 26302707
• Report Number: 1030489-2015-02437
• 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: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2009
• Device Catalogue Number: 7510800
• Device Lot Number: M110601AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2015
• 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: 112