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 Discomfort (2330); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

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) 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 and underwent the following procedures: removal of instrumentation and exploration of fusion from l4 to s1.Placement of nonsegmental instrumentation at l3-l4 using the pedicle screw instrumentation system.Right sided facetectomy and resection of synovial cyst for decompression of lumbar stenosis and right lateral recess stenosis using the intraoperative microscope and microneurosurgical technique.Transforaminal lumbar interbody fusion at l3-l4 using the peek interbody cage as well as interbody arthrodesis using milled locally harvested bone from the products of decompression as well as bone morphogenic protein.Posterolateral fusion at l3-l4 using milled allograft bone and bone morphogenic protein, both along the facet joint and the intratransverse position on the left side.Resection of subcutaneous lipoma at the inferior portion of the lumbar wound.Use of ancef 2 gm iv given within 1 hour of incision time.Use of intraoperative neuromonitoring.Use and interpretation of intraoperative fluoroscopy.As per op-notes, " the subcutaneous tissues were dissected with the bovie cautery and a subperiosteal dissection exposing l3 to the sacrum, including his instrumentation from l4 to the sacrum was performed.A this point, it was a system that had a 7 sided set screw that threaded onto the pedicle saddle.This was a system that had no instrumentation to remove.Because of this, the high speed drill using a metal cutting bur was used to section the rod connecting the pedicle screws and then this rod was used to back out the screws.The left s1 screw appeared to be fractured mid shaft; otherwise the rest of the screws were tightly in place.Pulling up on the screws created a single solid mass that moved from l4 to the sacrum.Bone graft from our products of decompression was packed in the disc space, pushed over to the side and then a 12 mm x 26 mm peek interbody cage was packed with bone morphogenic protein and then tamped into the disc space under direct vision.After this was done , the wound was copiously irrigated using bacitarian and pulsa jet lavage irrigation and then arthrodesis on the left side was completed using the high speed drill by arthrodesing the facet joint as well as the intratransverse position at l3-l4 and then bone morphogenic protein sponges wrapped around milled allograft bone were packed on the left side avoiding the right side foraminotomy and any contact with the nerves."the patient tolerated the procedure well.On an unknown date post-op, patient alleged unspecified injuries due to use of rhbmp-2.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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: 5978999
• MDR Text Key: 55669578
• Report Number: 1030489-2016-02662
• 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

• Date FDA Received: 09/27/2016
• 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: 09/06/2016
• 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