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 Death (1802); Injury (2348)

Event Type  Injury  

Event Description

It was reported that in 2006, the patient presented to the doctor for treatment for lower back pain and right leg pain.The patient's first surgery was on (b)(6) 2006, the doctor's pre-operative diagnosis was l5¿s1 herniated nucleus pulposus and low back pain.The doctor performed a l5-s1 discectomy, during which rhbmp-2/acs was used.The patient's second surgery was on (b)(6) 2007, the pre-operative diagnosis was l5-s1 disc degeneration, status post discectomy.The doctor performed an l5-s1 transforaminal lumbar interbody fusion, during which rhbmp-2/acs was used.The patient's third surgery was on (b)(6) 2008, the pre-operative diagnosis were status post transforaminal lumbar interbody fusion l5-s1, scroiliac joint syndrome.The doctor performed re-instrumentation of posterior spinal fusion with change to peek rods and screw revision, s1, right side, during which rhbmp-2/acs was used.The patient's fourth surgery was on (b)(6) 2012, the pre-operative diagnosis and lumbar spinal stenosis l5-s1 right side; lumbar foraminal stenosis l4-l5 left side; lumbar radiculopathy l5-s1 right side.The doctor performed a lumbar hemilaminectomy l5-s1 right side; lumbar foraminotomy l5-s1 right side; lumbar lateral recess decompression l5-s1 right side using baxano along with rhbmp-2/acs.The patient's final surgery was on (b)(6) 2012, the pre- operative diagnosis was a hematoma lumbar wound.The doctor performed evacuation of the hematoma lumbar wound, irrigation, and drainage of the lumbar wound, placement of superficial lumbar drain.It was reported that until her death on (b)(6) 2014, the patient continued to suffer lower back and right leg pain.During the 17-month period after her fifth surgery to the date of her death on (b)(6) 2014, the patient looked for medical help, but no doctor would take her as a patient.When she was in severe pain, she would go to the local emergency room for treatment.It was reported that the doctor used a posterior surgical approach and used rhbmp-2/acs in multiple spine surgeries.

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

• 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: 4966894
• MDR Text Key: 6322686
• Report Number: 1030489-2015-01910
• 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: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• 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
• Date Manufacturer Received: 07/06/2015
• 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): Required Intervention