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

Catalog Number 7510600

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

Patient Problems Neuropathy (1983); Loss of Range of Motion (2032); Discomfort (2330)

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) 2004: the patient presented for a follow-up visit with dysesthetic numbness in the right anterior thigh which was improving.On (b)(6) 2004: the patient presented for a follow-up visit.Patient was a little stiff and sore.She had the dysesthetic numb spot in the anterior portion of her right thigh.Ap and lateral x-rays demonstrated consolidation of the interbody bone graft.There was no evidence of loss of fixation or change in alignment.On (b)(6) 2004: the patient presented for a follow-up visit.Occasionally legs go to sleep if she sits too long.She had an occasional ache in the lower leg; she uses a lidoderm patch on the right thigh.X-rays, ap and lateral of lumbar spine, demonstrated good alignment to the fusion.There was no evidence of looseness or loss of fixation of the implants.On (b)(6) 2004: the patient presented for an early follow-up visit where she reported being clumsier on her feet.She was catching her toe.She had stumbled several times.Impression: patient was 4 months out from her fusion and doing okay.She has started to experience some change in her functional level which was of concern.X-rays, ap and lateral, showed good alignment to the lumbar spine with no evidence of dislodgment or change in the implants.On (b)(6) 2005: the patient presented for a follow-up to evaluate her ct myelogram which showed she had fused solid at l4-5 but not l5-s1.5-1 had gas in it.On (b)(6) 2005: the patient presented with complaint of worsening back pain where it was prior to surgery and has radiation into both legs.X-rays in the office, ap and lateral, demonstrate instrumented fusion.There was question whether one screw at s1 was broken.There was angulation to it.There was no clear fracture line.There was lucency around the other screw.The graft at l5-s1 appeared intact.There was defined area of lucency over the top of the graft on the underside of l5.Flexion and extension did not show gross motion.L5-s1 was difficult to visualize because of overlying pelvic wings.On (b)(6) 2005: the patient underwent ct scan which revealed the graft was fractured but has not been displaced.The surrounding bone was becoming more accommodating to the fusion.There was no gross lucency but there was a little gas along the anterior edge of the l5-s i graft suggestive of motion.On (b)(6) 2005: the patient presented for a follow-up with complaint of still having back and lower extremity pain.On (b)(6) 2005: the patient underwent ct scan which revealed patient was not fused at ls-s1.She was solidly fused at l4-5.Myelogram does not show evidence of severe neurologic impingement or hypermobility.On (b)(6) 2006: the patient presented for a follow-up.Patient still has worsening low back pain with radiation down the right leg.She still has burning pain in the lower back and difficulty sitting.She has worsening s1 radiculopathy in the left leg.She was developing a straight leg raise sign on that side.On (b)(6) 2006: the patient presented for a follow-up.Patient complained of worsening low back pain.Pain was in a band-like distribution down her buttocks.She was having radiating left leg pain through the hamstring, calf and into the lateral aspect of her tibia.Pain has been more problematic over the last 6-8 weeks.X-rays in the office, ap and lateral of lumbar spine, demonstrated the instrumented fusion from 4 to the sacrum.Ap with good alignment and no evidence of any significant hardware failure.On the lateral there appears to be good consolidation at 4-5.She has some motion at 5-1 suggestive of loose screws and pseudoarthrosis.On (b)(6) 2006: the patient underwent ct scan which revealed she was not consolidated at ls-s1; she has frank gas in the disc space telling me that there was motion.There appears to be some micro consolidation across the facet joints.It may be beam hardening and/or volume averaging across the facet joints.On (b)(6) 2006: the patient was presented with pre-op diagnosis of pseudoarthrosis l5-s1.For which patient underwent revision and re-do anterior lumbar interbody fusion l5-s1 with residual discectomy l5-s1, removal of implants l5-s1, exploration of fusion and reinstrumentation at l4-l5 with application of prostatic device.Depuy acromed cougar interbody cage and use of bone morphogenic protein soft mordanic rhbmp-2/acs.Per op notes, the cougar cage was packed with bone morphogenic protein, inserted with good fit and purchase confirmed under ap and lateral fluoroscopic projections.A single hole kick out plate was placed anteriorly to keep the cage intact and all the irrigation had been done prior to placement of the bone morphogenic protein the abdominal fascia was closed.The patient tolerated the procedure well and no patient complications were noted.On (b)(6) 2006: patient got discharged after undergoing revision of an anterior lumbar interbody fusion l5-s1.On (b)(6) 2006: the patient presented for a follow-up visit status post fusion surgery.She was doing well after the revision fusion for pseudoarthrosis.Incisions were well healed.On (b)(6) 2007: the patient presented for a follow-up visit where she continues to be about the same.She has no new pain.She was not getting any better.She still has numbness and tingling in the legs, achiness in her back and gluteal region.On (b)(6) 2007: the patient underwent ct scan of lumbar spine in (b)(6) which showed solid anterior fusion at 4-5 and solid anterior and posterior fusion at l5-s 1 in completion of her fusion procedure.On (b)(6) 2007: patient reported via call some buzzing and tingling sensation through her legs.On (b)(6) 2009: the patient presented for a follow-up visit with complaints of left sided buzzing pain that radiated down her buttocks to her calf and foot.On (b)(6) 2009: the patient presented with chronic low back pain, she still has lower extremity pain and discomfort despite being fully decompressed and the time duration.On (b)(6) 2010: the patient presented for visit with chief complaint of low back and leg pain with diagnosis of lumbar radiculopathy and lumbar spondylosis.Assessment: patient has left-sided low back pain as well as radicular symptoms in the left leg corresponding to s1 area with additional some spread into l5 area as well.Neurologic exam was normal except for slight numbness in the fourth and fifth digit in the left foot.She has significant hindrance in activities of daily secondary to pain.It was likely that there was some neural irritation giving rise to the radicular symptoms or this may represent nerve injury type of pain secondary to the disc herniation that she initially sustained.On (b)(6) 2010: the patient presented for visit with chief complaint of low back and leg pain with diagnosis of lumbar rad iculopathy and lumbar spondylosis.For which patient underwent transforaminal epidural steroid injection.On (b)(6) 2010: the patient presented for follow-up visit after undergoing for epidural steroid injection.Assessment: neuropathic pain and some radicular symptoms improved after transforaminal epidural steroid injection.

• 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: 5047008
• MDR Text Key: 24778883
• Report Number: 1030489-2015-02154
• 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: 08/03/2015

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
• Device Expiration Date: 11/30/2008
• Device Catalogue Number: 7510600
• Device Lot Number: M115010AAG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2015
• 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