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 Unspecified Infection (1930); Muscle Spasm(s) (1966); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that on (b)(6) 2007 patient with no prior history of back pain presented with left low back pain which went to her left leg and down into the anterior medial knee sustained from a mva on (b)(6) 2007.Pain increased by standing, walking, bending and lifting.Mri taken on (b)(6) 2007 shows advanced l5/s1 disc degeneration, with foraminal stenosis.X-rays taken on (b)(6) 2007 show reduction of disc height at l5/s1 and calcification of the anterior pelvis to the level of iliac crest.Patient was diagnosed with l5/s1 degenerative disc disease, mechanical low back pain and left leg pain.For this doctor prescribed l5/s1 epidural steroid injection.On (b)(6) 2007 patient presented with increased pain and agreed for surgery on which doctor prescribed loratab 7.5 mg and arranged for surgery after explaining to patient about the complications involved.On (b)(6) 2007 patient underwent l5 laminectomy and foraminotomy with l5/s1 interbody and posterolateral fusion with cages, screws and rods as well as demineralized bone matrix, rhbmp-2 and local autograft bone.Rhbmp-2 was used in a 7mm cage which was placed in anterior disc space of l5-s1 with morsellized local autograft on each side in lateral gutters.On (b)(6) 2007, 2 weeks after surgery patient presented with muscle spasms and low back pain after sitting for prolonged periods.However, there was no leg pain.Doctor diagnosed possible urinary tract infection.Patient underwent ap and lateral lumbar spine x-rays which showed interbody spacer with posterior screws and rod instrumentation.Bonegraft was seen in lateral gutters.L5 laminectomy defect was present.No unexpected findings.On (b)(6) 2007 patient presented with pain after a trip to the springs.Patient underwent ap and lateral lumbar spine x-rays which showed interbody spacer with posterior screws and rod instrumentation.There was no evidence of implant failure, fracture or dislocation.Normal bone mineralization.On (b)(6) 2008 patient had very little pain.Patient underwent ap and lateral lumbar spine x-rays which showed a slight left degenerative scoliosis.There was no dynamic instability on lateral bending.Patient had a radiographically solid l5-s1 interbody and posterolateral fusion without any dynamic instability l4/5.There were no fractures or dislocations.Normal bone mineralization and soft tissue shadows.There was no spondylolisthesis or spondylolysis.On (b)(6) 2008 patient presented with reduced pain (3-5 on a scale of 10).Patient underwent ap and lateral lumbar spine x-rays which showed interbody spacer with posterior screws and rod instrumentation in very satisfactory position.No lucency around screws and no evidence of implant failure.There was no spondylolisthesis.There was no evidence of any angular changes at l5/s1 and no adjacent segment breakdown with physiologic motion in the remainder of the lumbar spine.

• 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: 5027064
• MDR Text Key: 23912896
• Report Number: 1030489-2015-02065
• 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: 07/27/2015

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: 08/25/2015
• 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: 73