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 Neuropathy (1983); Pain (1994)

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) 2012 the patient underwent a surgical procedure which included a multi-level (l4-5 and l5-s1) posterior lumbar interbody fusion with milled auto allograft, bilateral l4-s1 posterolateral grafting with milled auto allograft, and the insertion of concorde bullet cage with rhbmp-2/acs; bone graft component at l4-5 and l5-s1.On (b)(6) 2012 the patient reported back pain.Her primary care physician advised her that her back pain was due to her job as a housekeeper because he believed the pain was muscular in origin.On (b)(6) 2013 the patient reported pain radiating down her left buttock and left leg.Her primary care physician diagnosed recurrent back pain/sciatica and instructed her to follow up with an orthopaedic specialist.On (b)(6) 2013 the patient saw an orthopaedic specialist, who informed her that her back pain is to be expected following the surgical procedure and prescribed physical therapy and pain medication.On (b)(6) 2013 the patient saw a sports medicine specialist due to continued back and leg pain.The sports medicine specialist initially attributed plaintiff's symptoms to sacroiliac joint dysfunction.On (b)(6) 2013 the sports medicine specialist found the symptoms being more radicular rather than sacroiliac joint based in nature, ordered a computed tomography (ct) scan of the patient's lumbar spine.The report of the (b)(6) 2013 ct scan of the patient's lumbar spine stated that "expansile bone formation along the transforaminal tracts at l4-5 and l5-s 1 contribute to left sided neural foraminal stenosis at these levels, and may be related to placement of bmp." on (b)(6) 2013 the patient saw her primary care physician for a general physical.Her primary care physician diagnosed chronic back pain and ordered continued physical therapy and pain medication.On (b)(6) 2013 the patient's sports medicine specialist discussed the results of the (b)(6) 2013 ct scan with the patient.On (b)(6) 2013 the patient presented to orthopaedic specialist for consult.On (b)(6) 2013 the patient presented to discuss her ct scan of her lumbar spine, which revealed a "large amount of heterotopic bone on the left side of the canal at l4-l5 and l5-s1." on (b)(6) 2013 the patient presented with a copy of the operative report of her surgical procedure.The doctor explained to the patient that rhbmp-2/acs was used in the surgical procedure and was the likely cause of her symptoms.

• 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: 5334193
• MDR Text Key: 34645147
• Report Number: 1030489-2015-03615
• 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: 12/01/2015

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: 12/01/2015
• Initial Date FDA Received: 12/30/2015
• 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