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 Cyst(s) (1800); Neuropathy (1983); Pain (1994); Stenosis (2263)

Event Type  Injury  

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.

Event Description

It was reported that on: on (b)(6) 2006: the patient was pre-operatively diagnosed with: severe degenerative disk disease with intractable low back pain plus lumbar radicular pain, l4-l5, l5-s1 and underwent the following procedures: l4 laminectomy, complete bilateral.L5 laminectomy, complete bilateral.Foraminotomy l4,l5, and s1 bilateral.Pedicle screws l4, l5, and s1 bilateral.Transverse process fusion l4,l5 and s1 bilaterally.Continuous neurophysiologic emg monitoring x2 hours.The patient was also pre-operatively diagnosed with degenerative disc disease with interactable low back pain plus radiculopathy l4-l5 and l5-s1 and underwent the following procedures: anterior lumbar discectomy at l4-l5.Anterior lumbar discectomy at l5-s1.Anterior lumbar interbody arthrodesis with peek plus bone morphogenic protein l4-l5.Anterior lumbar interbody arthrodesis with peek plus bmp l5-s1.Buttress plate anterior l4 and l5.Use of fluoroscopy.Continuous neurophysiologic, electromyographic monitoring x 2hours.As per op-notes, "the 15 mm spacer was packed with bone morphogenic protein, which had been placed on a collagen sponge as per protocol and allowed to set the proper amount of time.The spacer was then driven securely into the l5-s1 interval.Once it was felt that satisfactory position had been obtained, a slightly bent cervical plate was placed over the interval between l5-s1 with anchor screws and set screws being placed to maintain position for the anterior border of the l5-s1 disc space.Then same procedure was done at l4-l5 level." the patient tolerated the procedure well.The patient also underwent retroperitoneal exposure of l4-l5 and l5-s1.On (b)(6) 2011: the patient was pre-operatively diagnosed with: adjacent segment deterioration at l3-l4 above a previous l4 to the sacrum instrumented fusion by another surgeon.Lipoma at the inferior portion of incision that is causing pain and discomfort.Synovial cyst causing spinal stenosis at the adjacent segment deterioration causing severe right lumbar radiculopathy and back pain.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5979000
• MDR Text Key: 55668752
• Report Number: 1030489-2016-02663
• 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,Followup
• Report Date: 09/06/2016

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: 09/06/2016
• Initial Date FDA Received: 09/27/2016
• Supplement Dates Manufacturer Received: 09/06/2016
• Supplement Dates FDA Received: 09/25/2017
• 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