MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Device Problems Malposition of Device (2616); Extrusion (2934)

Patient Problems Pain (1994); Scarring (2061)

Event Type  Injury  

Event Description

It was reported that in (b)(6) 2008, patient began experiencing left leg numbness and, underwent an mri of his lumbar spine.The report indicated: mild to moderate findings at l3-l4, l4-l5, and l5-s1; disc space narrowing and a mild bulge at l4-s1 with a paramedian disc protrusion; and mild canal and mild to moderate foraminal encroachment.In jun 2009, patient sought medical treatment.On (b)(6) 2009, patient underwent x-rays of his lumbar spine which revealed no disc space narrowing and only very minimal anterolisthesis of l2-l3, noting diffuse osteophytes and vascular calcification.Later patient underwent 4 surgeries 2009 to 2013.In (b)(6) 2009, patient underwent surgery on lumbar spine installing hardware and an axialif plug.The patient was implanted with rhbmp -2/acs.Post-op, patient alleged that she suffered from extreme lower back and buttock pain that was much worse than the pain he experienced prior to the surgery.In (b)(6) 2009, a post-operative ct scan revealed that improperly placed bmp-2, which had not been placed in the required lt-cage, had extruded and was causing severe nerve impingement; the very issue the first surgery was supposed to remedy for which patient has to undergo an ¿axialif redo.On (b)(6) 2009, patient underwent surgery to remove the extruded material from the previous axialif.The patient was implanted with rhbmp-2/acs.Allegedly post-op, patient continued to suffer from increase lower back pain, gaining no relief from the ¿redo¿ surgery.On (b)(6) 2010, patient underwent an emg procedure.The emg revealed that the left l5-s1 radiculopathy was still present, despite the two surgeries.On (b)(6) 2010, an mri at (b)(6) revealed recurrent l5 herniation.Upon information and belief, on (b)(6) 2010, at (b)(6), patient underwent surgery consisting of a revision of a left l4-l5, l5-s1 lamin oforaminotomy.The operative report also noted that there was ¿extensive scarring¿ associated with the previous surgeries.No implants were listed on the implant log.In a post-operative x-ray taken on (b)(6) 2010, the radiologist¿s report noted ¿diffuse hypertrophic spurring¿ in patient's lumbar spine.On (b)(6) 2011, another x-ray noted ¿spurring¿ in this same location, and on (b)(6) 2011, an mri report indicated that despite having undergone three surgeries, patient still had a bulging disc at l5-s1.On (b)(6) 2012, patient underwent another revision surgery to address the problems on patient¿s l4-l5 and l5-s1.Operative notes indicate that surgeon encountered a ¿tremendous¿ and ¿immense amount of scar¿ tissue in the l5-s1 area.After three failed revision surgeries, surgeon continued to report that patient was not responding to non-operative means.Since the failed surgeries under surgeon's care, patient has not worked a single day.He is now suffering under complete disability as the result of constant, extreme pain.

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.

• 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: 4959524
• MDR Text Key: 20153779
• Report Number: 1030489-2015-01834
• 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: 08/03/2015
• 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
• 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