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 Edema (1820); Muscle Spasm(s) (1966); Swelling (2091); Thyroid Problems (2102); Stenosis (2263); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that (b)(6) 2008: patient presented with l4-l5, ls-81 degenerative disc disease.Operation: l4-l5, l5-s1 anterior lumbar interbody fusion using peek.L4-l5, l5-s1 anterior spinal instrumentation using plates.Op notes: a 14 mm cage was placed at l5-s1 filled with rh-bmp2/acs.The position was found to be satisfactory on cross table fluoroscopic image.At l4-l5 the interval was dilated to 18 mm.An 18mm peek cage was then inserted.This composed the fusion portion of the procedure.A 25 mm lx plates were then secured to the bodies of l4, l5, and s1.The position of the plates was found to be satisfactory on a cross table and ap fluoroscopic image.On (b)(6) 2008: patient is here for follow-up reevaluation of his right knee, status post arthroscopy, which revealed some arthritic changes both the femoral and tibial surfaces, specifically in the medial compartment impression: right knee pain.Right knee osteoarthritis.On (b)(6) 2008: patient presented with grade ii l5 anterolisthesis with bilateral l5-s1 spondylolysis.Right lower extremity radiculopathy.On (b)(6) 2008: patient presented with l4-l5, l5-s1 degenerative disc disease.Patient presented with discharge diagnosis: l4-l5, l5-s1 anterior lumbar interbody fusion.Procedure performed: retroperitoneal exposure of the anterior spine l4-5, l5-s1 for anterior lumbar interbody fusion.Placement of preclude gore-tex anti-static patches l4-5 and l5-s inter op notes: the patient had a significantly anterior displacement off the l5-s1.Op notes: once the lumbar were taken and the connective tissue attachments freed we were now able to reflect the iliac vein laterally and the vena cava to the right to allow for exposure of the l4-5 level.This being appropriately accomplished we then placed needles in the l4-5 and l5-s1 space and the c-arm was utilized to take an x-ray of the back.The patch was then anchored down to the ls body and once this was done we then used the retractors to allow us to place the edges of the patch out laterally and under the vessels, both medially and laterally.On (b)(6) 2008: patient presented with l4-l5, l5-s1 degenerative disc disease.Low back pain.Left knee superficial abscess.On (b)(6) 2008: patient presented with l4-l5 and l5-s1 degenerative disc disease low back pain.Left knee superficial abscess.Ap and lateral views of the lumbar spine demonstrates the hardware to be well seated.On (b)(6) 2008: patient presented with l4-l5 and l5-s1 degenerative disc disease.X-rays reveal well-positioned hardware, and no evident change in position.On (b)(6) 2008: patient presented for follow-up.Patient presented with l4-l5, l5-s 1 degenerative disc disease.Low back pain (resolved).Right index finger extensor surface lesion.X rays show the instrumentation to be in good position and consolidation of his anterior graft.On (b)(6) 2008: patient presented with right knee osteoarthritis.Patient underwent x-rays in ap, lateral, and patellar skyline views of the right knee which demonstrate moderate medial joint space narrowing.No fractures seen.On (b)(6) 2008: patient presented with l5-s1 lytic spondylolisthesis (grade 2).L4-l5 and l5-s1 degenerative disc disease.Low back pain.Right knee osteoarthritis.X-rays show fusion to be consolidated without motion.On (b)(6) 2008: patient presented with status post l4-l5 and l5-s1 alif.Impression: six months status post above-mentioned surgery, doing well with some increase in pain from physical therapy.X-rays show fusion to be consolidated without motion.On (b)(6) 2009: patient presented with l4-l5 and l5-s1 degenerative disk disease.Low back pain.X rays, ap, lateral, flexion, and extension views show no evidence of motion on his dynamic films.On (b)(6) 2009: patient presented with back pain, status post anterior lumbar intervertebral body fusion.Impression: postoperative findings described in detail in the body of the report above.Please refer to the body of the report regarding the postoperative findings.Note is made of a grade 1 anterior spondylolisthesis of l5 on s1 associated with bilateral spondylolysis and bilateral neural foraminal narrowing for which clinical correlation is recommended.There is a finding in the anterior epidural space at the level of the l4 vertebral body which could be due to a herniated disk fragment.This is not associated with significant central canal stenosis or lateral recess narrowing.On (b)(6) 2009: patient underwent ct of the lower extremity.Impression: diffuse subcutaneous edema/ inflammatory changes with mild thickening of the superficial fascia, findings which could be seen in cellulitis.No fluid collections seen.On (b)(6) 2009: patient presented with l4-l4, l5-s1 degenerative disc disease.Chronic back pain.X-rays shows what appears to be a solid fusion across the l4-l5 interval.On (b)(6) 2009: patient presented with right sciatica.Right osteoarthritis.L5-s1 spondylolisthesis.L4-l5 and l5-s1 degenerative disc disease.Bilateral l5-s1 foraminal stenosis.On (b)(6) 2009: patient underwent ap, standing, lateral, and sunrise of both knees show medial compartment narrowing on the right with near bone-on-bone.On (b)(6) 2009: patient presented with l5-s1 spondylolisthesis, l4-l5 and l5-s1 degenerative disc disease, right sciatica, and bilateral knee osteoarthritis.On (b)(6) 2009: patient presented with varus osteoarthritis, stage 3, right knee, evaluate for possible unicompartmental arthroplasty.X-rays from 2008 demonstrate progressive varus osteoarthritis of his knee.Impression: osteoarthritis, progressive, degenerative, right knee.On (b)(6) 2009: patient presented with l5-s1 spondylolisthesis, l4-l5 and l5-s1 degenerative disc disease, and right sciatica.Assessment: status post l4-l5 and l5-s1 alif in (b)(6) 2008.Chronic low back pain.On (b)(6) 2011: patient presented with right lower extremity pain and swelling.Impression: no evidence of dvt within the right lower extremity.On (b)(6) 2014: patient underwent x-ray of the lumbar spine.Impression: no acute fracture or evidence of hardware failure.Grade 1 spondylolisthesis of l5 on s1 has worsened since 2009.Patient underwent x-ray of the knee right trauma.Impression: status post total knee replacement with small knee joint effusion.No hardware failure or fracture.Patient underwent ct of the cervical spine.Impression: no acute cervical spine fracture.Mild straightening of the cervical spine likely due to muscle spasm or position.Mild degenerative changes of the cervical spine.Concavity of the left thyroid cartilage may be the sequela of prior injury.Soft tissues otherwise normal.On (b)(6) 2014: patient underwent x-ray of the right hip region.Impression: no fracture or dislocation of the pelvis or right hip.Status post l4-s1 spinal surgery.

• 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: 5059623
• MDR Text Key: 25107610
• Report Number: 1030489-2015-02223
• 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: 08/11/2015

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2015
• 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