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

Catalog Number 7510400

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

Patient Problems Dysphagia/ Odynophagia (1815); Hypoxia (1918); Pain (1994); Hernia (2240); Stenosis (2263); Depression (2361)

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 per medical records on (b)(6) 2005 patient presented with chest pain.Impression: negative chest.On (b)(6) 2005 patient underwent myelogram lumbar test.Impression: insensitivity of the study at l5-s1.There is question of swelling of the left descending s1 nerve rootlet.Post myelogram ct to follow."ct lumbar spine with contrast" impression: ~4-s: there is a broad-based disc bulge, non-lateralizing, unchanged since the prior study.~3-4, l2-3, l1-2, and t12~l1: no abnormality and no change.On (b)(6) 2005 patient underwent "ct lumbar spine with contrast." impression: left posterolateral extrusion of contrast at the ls-s1 level.It was noted on discogram that this level was positive for reproduction of the patient's symptomatology."diskogram lumbar" impression: findings of abnormal disk at each lumbar level.On (b)(6) 2005 patient underwent "spine lumbar 2/3 views" impression: satisfactory alignment.On (b)(6) 2005 patient underwent "mammo digital screen bilateral." findings: comparison made to prior examination.There is no mass, architectural distortion or suspicious micro calcification.On (b)(6) 2005 patient admitted with following diagnosis: failed back syndrome, recurrent disk herniation, far lateral disk herniation with spondylolisthesis l5-s1.Procedure: decompressive laminectomy and mesial facetectomy, foraminotomy l5-s1 with the microscope, harvesting autologous graft, total discectomy l5-s1, anterior and posterior fusion 360 degree fusion via a single incision and anterior effusion of the tlif approach l5-s1 and posterior lateral mass fusion and pedicle screw fixation l5-s1.Per-op notes: the patient's autologous bone was packed at l5-s1 interspace and followed by peek implant filled with bmp and the patient's autologous bone was tapped into place completing a transforaminal fusion anteriorly.After the anterior fusion, remaining of patient's bone was then placed in a bmp sponge to the transverse processes at l5-s1 and remaining facet joint completing the posterior dorsal fusion.No known complications.On (b)(6) 2005 patient discharged with following discharged diagnosis: failed back syndrome.Hypoxia secondary to medication.Asthma.On (b)(6) 2005 patient admitted with complaining of "getting worse and worse." on (b)(6) 2005 patient discharged with following discharged diagnosis: chronic pain, asthma, moderate, generalized anxiety disorder, bipolar disorder depressed improved at time of discharge.On (b)(6) 2005 patient underwent "us abdomen complets" impression: normal sonographic evaluation of the abdomen.On (b)(6) 2005 patient admitted with medical emergency.On (b)(6) 2005 patient discharged with following discharged diagnosis: chronic pain, asthma, moderate, generalized anxiety disorder, bipolar disorder depressed improved at time of discharge.On (b)(6) 2005 patient admitted with acute myocardial infarction, mania, depression, hypokalemia.On (b)(6) 2007 patient presented with pelvic pain.Impression: no abnormality identified.Non visualization of uterus and ovaries incidentally noted."mammo digital screen bilateral" impression: no findings of malignancy.On (b)(6) 2008 patient presented with following reason: dysphagia.Findings: at the esophageal cardia, a small hiatus hernia was present.The hiatal narrowing was 40 cm.From the teeth.The gastroesophageal junction was 38 cm.From the incisors.The stomach was examined and no abnormalities were seen.The small bowel was examined and no abnormalities were seen.The ge junction was serrated <(><<)> 2cm.On (b)(6) 2008 patient examined because of: left hand injured.Impression: no definite acute fracture identified.On (b)(6) 2008 patient underwent "us-~domen." impression: normal abdominal ultrasound.On (b)(6) 2008 patient underwent "mr-lums spine w/wo c," impression: post-surgical changes from prior l5-s1 fusion on the left side with apparent protrusion of the interbody spacer at ls-s1 posterolaterally outside of the disk space causing some left-sided thecal sac effacement.This, in addition to facet hypertrophy at this level, causes left neural foraminal stenosis.Facet hypertrophy throughout the lower lumbar region causing mild neural foraminal narrowing at the level of l3-l4 and l4-l5.Mild anterolisthesis of l3 on l4.

• 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: 5101196
• MDR Text Key: 26791950
• Report Number: 1030489-2015-02425
• 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: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510400
• Device Lot Number: M114004AAE
• 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: 82