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 Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that the patient had been diagnosed with degenerative disc disease for which treatment and surgery had given in (b)(6) 2009.The patient still experienced lower back pain.The patient made several office visits between (b)(6) 2010.On (b)(6) 2010, the patient underwent surgery of an anterior cervical discectomy and fusion from c3-c4, c4-c5, and c5-c6 (¿the first surgery¿).The patient was implanted with rhbmp-2/acs.On (b)(6) 2011, the patient underwent surgery of a lateral lumbar interbody fusion from l4-l5 (¿the second surgery¿).The patient was implanted with rhbmp-2/acs.On (b)(6) 2011, the patient underwent surgery of a hemilaminectomy and foraminotomy from l3-l4 (¿the third surgery¿).The patient was implanted with rhbmp-2/acs.On (b)(6) 2011, the patient had gone into an emergency room with wound drainage, a fever, and an increase in her white cell count.On (b)(6) 2011, the patient underwent surgery of an irrigation and debridement surgical wound to treat for mrsa (¿the fourth surgery¿).Post-op, the patient began to suffer from pain in her right leg, which became sensitive to the touch.Also, the patient began to have pain in her right arm along with weakness in that hand.On (b)(6) 2012, the patient underwent surgery of a foraminal stenosis decompression from c5-c6, c6-c7, and c7-t1 (¿the fifth surgery¿).The patient was implanted with rhbmp-2/acs.Post-op, the patient began to suffer from muscle spasms and severe pain in her neck and right shoulder.The patient also recommended to increase narcotic pain medication.On (b)(6) 2013, the patient underwent surgery of a lumbar interbody fusion from l3-l4 (¿the sixth surgery¿).The patient was implanted with rhbmp-2/acs.Post-op, the patient suffered from constant pain worsen than anything.As a result, the patient required higher doses of pain medications to counteract the pain.The patient was no longer able to walk without assistance and needs help with simple tasks.

Manufacturer Narrative

(b)(4).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: 4960408
• MDR Text Key: 6639393
• Report Number: 1030489-2015-01845
• 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

• 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: 07/06/2015
• Initial Date FDA Received: 08/03/2015
• 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