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 Nausea (1970); Pain (1994); Vomiting (2144); Injury (2348); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

(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

Per medical records, it was reported that on: (b)(6) 2010 , patient underwent mri lumbar spine.Impression: 1.Scoliosis.2.No change in the circumferential bulging at l5-s1 which deforms the sac and mildly compresses the left l5 ganglion.3.No change in the grade i degenerative l4-5 listhesis that deforms the sac and results in contact with the right l4 ganglion.4.Progression of spondylosis results in new mild central stenosis at l3-4.5.Spondylosis deforms the sac at l2-3.6.Facet arthropathy in the lower lumbar spine.7.Stress reaction in the l4 and right l3 pedicles.8.Severe dilatation of the distal common bile duct.(b)(6) 2011, patient also underwent mri lumbar spine.Impression: 1.Little interval change.2."5" thoracolumbar scoliosis.3.C ircumferential ls-s1 and scoliosis result in mild compression of the left ls ganglion.4.Stable grade i l4-s degenerative listhesis without neural impingement.S.Stable spondylosis at l3-4 and l2-3.6.Facet arthropathy.7.Mild stress reaction in both l4 pedicles.8.The common bile duct dilatation has resolved (b)(6) 2011, patient underwent mri of right knee <(>&<)> cervical spine.Impression (knee ): medial meniscus tear.Impression (spine) : degenerative disc disease in c5-6 <(>&<)> c6-7.(b)(6) 2011, patient also underwent xr of cervical spine.(b)(6) 2011, patient underwent mri lower extremity joint wo contrast right.Impression: there is no abnormal bone marrow signal in the right femoral head or neck.2.There is a small nonspecific area of bone marrow signal abnormality in the inferomedial aspect of the pubis adjacent to the right side of the symphysis of uncertain etiology and significance.8 <(>&<)> (b)(6) 2011, the patient presented with back pain and underwent mri cervical <(>&<)> lumar w-wo contrast.Impression: 1.Appears multilevel disc disease.2.Normal enhancement in fusion.3.Ample subarachnoid space surrounding the posterior aspect of the cord.(b)(6) 2012; (b)(6) 2012; (b)(6) 2012; (b)(6) 2012; (b)(6) 2012, per medical records, the patient presented for evaluation of her health condition.Patient also underwent radiological examination.Impression ((b)(6)): linear scarring in the right base.Otherwise, no evidence of acute cardiopulmonary disease (b)(6) 2012, per medical records, the patient presented for evaluation of her health condition.(b)(6) 2012 , the patient presented with preoperative diagnosis: degenerative spondylolisthesis l3-4 <(>&<)> l4-5 with spinal stenosis and scoliosis.Per the medical records, following operation was performed: staged anterior and posterior reconstruction consisting of a de-compressive laminectomy l3, l4, l5 with posterolateral fusion l3-l5 with mesa spinal -instrumentation with local bone gran and rhbmp/2, and harvesting of subcutaneous free fat graft.During the procedure, under fluoroscopic guidance, the pedicles of l3, l4, and l5 were probed.They were tapped to 6.5 mm diameter and 6.5 mm x 50 mm polyaxial screws were placed bilaterally at l3 and l4 and a 6.5 mm x 45 mm polyaxial screws were placed bilaterally at l5.The morselized local graft was then wrapped with 2 rhbmp/2 soaked collagen sponges and laid in the lateral gutters, and additional remaining local graft was packed in both lateral gutters then.No postop complications were noted.Radiographical monitoring done during the procedure.(b)(6) 2012, patient underwent xr of lumbar spine.(b)(6) 2012, patient presented for postoperative f/u visit.(b)(6) 2012 , patient presented for f/u and underwent radiological examinations.(b)(6) 2012, patient presented with back pain and leg pain underwent ct of cervical spine.Impression: multilevel cervical spondylosis changes are noted as described above.(b)(6) 2012 , the patient underwent ct of thoracic spine w contrast.Impression: scoliotic curvature is noted.(b)(6) 2012, the patient underwent xr of myelogram lumbosacral spine.(b)(6) 2012, the patient underwent xr of lumbarsacral spine.(b)(6) 2012; (b)(6) 2012, presented for ct of lumbar spine wo contrast, post her fusion surgery.Impression ((b)(6)): 1.Postsurgical changes status post posterior fusion involving l3-l5 without radiographic evidence of hardware complications.2.Multilevel degenerative changes greatest at l5/s1 where there is a disc bulge vs protrusion which is asymmetrically larger in the left lateral region resulting in indentation of the ventral margin of the thecal sac and narrowing of left neural foramen.(b)(6) 2012, patient also underwent xy of lumbar spine.Impression: the patient's undergone posterior fixation from l3-5 with rod and screws and disc spacing material.There is no subluxation with flexion or extension.(b)(6) 2012, patient presented with abdominal pain, nausea, vomiting, diarrhea.She underwent ct abdomen-pelvis w contrast.Impression: no acute abnormality is noted in the abdomen or pelvis.Overall, no significant change is identified in comparison to the previous study, as discussed above.(b)(6) 2012, per medical records, the patient presented for evaluation of her health condition.Patient also underwent radiological examination.Impression (xray): nonspecific bowel gas pattern.Impression (ct abdomen pelvis): colonic diverticulosis without evidence of diverticulitis.Mild focal bladder wall thickening anteriorly.No definite evidence of choledocholithiasis.(b)(6) 2012, patient underwent xr /chest.Impression: sub segmental atelectasis in the bilateral lower lobes.(b)(6) 2012 , the patient made an acute visit with right knee pain.(b)(6) 2012, patient underwent radiological examination of knee, ultrasonic guidance, arthrocentesis.Impression; mild change of arthritis, (b)(6) 2012, patient presented with following preoperative diagnosis: 1.Right medial meniscus tear.2.Chondromalacia of the medial femoral condyle.She underwent following procedure: 1.Right knee arthroscopy.2.Arthroscopic partial medial meniscectomy, 3.Chondroplasty of the medial femoral condyle, lateral femoral condyle, lateral tibial plateau, and patellofemoral trochlear groove.(b)(6) 2012 , patient presented for f/u visit.(b)(6) 2012, the patient visited facility for general f/u after physical therapy , bilateral low back pain.(b)(6) 2012 , patient presented for follow up medication and underwent physical therapy after complaining of left arm pain and shoulder pain.(b)(6) 2013, the patient presented with neck pain and underwent mri cervical spine wo contrast.Impression: 1.Straightening of the normal cervical lordosis.2.Degenerative change greatest at c5-6 <(>&<)> c6-7.It is difficult to definitively compare with (b)(6) 2012 given differences in technique as that was a ct myelogram.(b)(6) 2013, patient presented for follow up and underwent physical therapy because of back pain /neck pain /left shoulder pain.(b)(6) 2013, the patient presented with neck pain and low back pain.F/u mri , pt (physical therapy).(b)(6) 2013, patient made office visit with chief complain of pain.After review of his medical records, patient was recommended for total knee replacement.(b)(6) 2013, patient presented for f/u underwent xr of lumbarsacral spine.Impression : status post fusion l3-4.Severe l5-s1 disc degeneration.(b)(6) 2013, patient presented for physical examination.(b)(6) 2013, patient presented for laboratory examinations.(b)(6) 2013, patient underwent radiological <(>&<)> laboratory examinations.(b)(6) 2013, patient underwent xr /chest.Impression: stable chest.(b)(6) 2013, patient was admitted to facility.Per medical records, she underwent mri lower extremity joint wo contrast.Impression: moderate tricompartmental osteoarthritis with a complex tear involving the medial meniscus.(b)(6) 2013, patient presented for preoperative clearance for surgery (b)(6) 2013, patient presented with following diagnosis; right knee degenerative joint disease and underwent knee surgery procedure.(b)(6) 2014, patient underwent xr of lumbar-sacral spine post low back pain.

• 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: 5060052
• MDR Text Key: 25110066
• Report Number: 1030489-2015-02241
• 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
• Device Expiration Date: 01/01/2014
• Device Catalogue Number: 7510800
• Device Lot Number: M111103AAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2011
• 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: 77