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 Sinus Perforation (2277); Osteolysis (2377); Chest Tightness/Pressure (2463)

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.

Event Description

It was reported that on (b)(6) 2008 the patient was admitted due to lumbar spondylolisthesis, l5-s1; left radiculopathy.He underwent lumbar spine fusion of l5-s1 with pedicle screw fixation and reduction of spondylolisthesis.The patient presented with a several-month history of severe radicular pain in both lower extremities, left worse than right, with pain in the posterolateral thigh and calf to the ankles.The patient also complained of progressively worsening lower back pain.He had failed conservative treatment including physical therapy as well as an epidural steroid injection.The patient's mri scan revealed disk space collapse with degeneration at the l5-s1 level with a grade 1-2 spondylolisthesis with foraminal stenosis bilaterally.The patient was brought to surgery for a spinal fusion and decompression with reduction of the spondylolisthesis at l5-sl with pedicle screw fixation and posterolateral arthrodesis.The patient underwent the following procedure: bilateral l5 laminectomy, medial facetectomy, lateral recess decompression, nerve root decompression and foraminectomy; bilateral l5/s1 discectomy; bilateral l5/s1 posterior segmental internal fixation with life spine arx rod and screw instrumentation 75 x45 screws at l5 and s1 bilaterally; bilateral l5/s1 posterior lumbar interbody grafting with peekcages 13 mm high packed with rhbmp-2/acs times two; bilateral l5/s1 posterolateral grafting with allograft, autograft, rhbmp-2/acs, demineralized bone matrix, tricalcium phosphate with left iliac bone marrow aspirate; partial reduction of l5/s1 spondylolisthesis; left iliac bone marrow aspirate; insertion of interbody peek device times two; morcellized allograft; intraoperative emg monitoring; intraoperative use of the cell saver.Per op notes: bilateral l5/s1 discectomy was performed.The end plate was curetted, prepped for grafting.Spurs were removed.Foraminectomy was performed thoroughly anteriorly and posteriorly after which the end plate was curetted and prepped for grafting and while distracting and reducing the interspace, the bilateral l5/s1 posterolateral grafting with peek cages 13 mm high packed with rhbmp-2/acs were placed uneventfully.After that was done, rods were used to connect the tulips of the screws and under compression secured to the screws with nuts and set screws torqued to the recomm ended torque.The cages were nicely seated.X-rays showed good placement of the screws on the cages.Hemostasis was achieved.Posterolateral grafting with allograft, autograft and rhbmp-2/acs and tricalcium phosphate mixed with left iliac bone marrow aspirate was done uneventfully.On (b)(6) 2008 the patient presented with a history of chest pain and underwent myoview myocardial perfusion study.Impression: normal exercise myoview myocardial perfusion study; normal left ventricular systolic function.On (b)(6) 2010 the patient underwent a radiological exam of the lumbar spine.A comparison was made with the one done on (b)(6) 2010.Impression: postsurgical changes at l5/s1 are redemonstrated and radiographically unchanged; grade 1 anterolisthesis l5 on s1 is redemonstrated and unchanged radiographically.Mild levocurvatore is also unchanged.The patient also underwent an mri.Comparison was done with the one on (b)(6) 2008.Impression: post-surgical changes at l5/s1, with posterior fusion and l5 laminectomy.Intervertebral disc spacer additionally seen.Unchanged grade 1 anterolisthesis of l5 on s1; no compression of the thecal sac at the l5/s1 level.Compromised evaluation of the exit neural foramina at this level due to artifact from fixation hardware; few small disc bulges of the lumbar spine without significant thecal sac narrowing.Neural foraminal narrowing as described above.Most prominent at l4/l5 with mild to moderate narrowing from disc bulge.No nerve root encroachment seen.The appearance is unchanged.On (b)(6) 2010 the patient presented with cold symptoms and complained of tightness in his chest.On (b)(6) 2010 the patient presented with sinusitis.On (b)(6) 2012 the patient presented with leg cramps.Patient reported history of restless leg syndrome and tics.On (b)(6) 2012 the patient presented for evaluation of foot pain.The onset has been sudden following no specific incident.Musculoskeletal lower extremity note: right foot: pain on palpation along achilles, extending into heals.Appropriate strength and rom.On (b)(6) 2012 the patient presented with the complaint of swollen ankle.On (b)(6) 2012 the patient presented with pain post trauma.Findings: three views of the right ankle.Four images submitted.No fracture or dislocation.No osteolytic or osteoblastic lesions.Some soft tissue swelling adjacent to the medial malleclus.Osseous and soft tissue structures are otherwise unremarkable.On (b)(6) 2012 the patient presented for a recheck of ankle swelling and paresthesia.On (b)(6) 2012 the patient presented with low back pain.Three radiological images of the lumbar spine were taken.Impression: stable postsurgical changes at l5-s1.Mild anterolisthesis l5-s1 is without distinct change; no distinct acute fracture or subluxation radiographically.If there remains concern clinically for radiographically occult fracture given trauma history, further investigation with ct would be recommended.On (b)(6) 2012 the patient presented with a complaint of acute thoracic back pain.Two views of thoracic spine were obtained.Findings: five non-rib bearing lumbar vertebral bodies are seen.There is fusion of the l5-s1 disc space with pedicle screws at l5 and s1.Vertebral body heights and alignment are normal.No acute traumatic injury or acute changes.

• 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: 5159716
• MDR Text Key: 28675629
• Report Number: 1030489-2015-02734
• 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
• Type of Report: Initial
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2010
• Device Catalogue Number: 7510600
• Device Lot Number: M110610AAJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2007
• 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: 93