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 Unspecified Infection (1930)

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.Multiple manufacturer's products were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported that on: (b)(6) 2007: patient presented with following pre-op diagnosis: neuromuscular focal lumbar scoliosis with extreme curvature and significant step off of lumbar vertebrae especially, severe progressive adult onset scoliosis with progressive deformity.Post-op diagnosis: severe progressive adult onset scoliosis with disk degeneration and pain.Patient underwent the following procedures: anterior spinal fusion l3-4, l4-5 and l5-s1.Discectomies, anterior l3-4, l4-5 and l5-s1.Use of machine structural allograft bone type cages for anterior spinal fusion l3-4, l4-5 and l5-s1.Use of neurological monitoring.Fluoroscopy was used.Anterior surgical approach, left sided, anterior l1 to l3 release from right side with interbody fusion and cage placement, l3 to s1 left sided anterior retroperitoneal approach with release and interbody cage placement, posterior t8 to s1 instrumentation, fusion and scoliosis correction with botox injection, placement of an internal "ebi" bone stimulator, use of local autograft bone for posterior fusion.Use of bone graft substitute for posterior spinal fusion, correction of severe scoliotic deformity using pedicle rod and screw system.As per op-notes: discectomies were performed at l3-4, l4-5 and l5-s1.Disk material as removed to allow mobilization of disk.Bone grafts were placed using angled bone grafts with thickest portion of bone graft on patient's right side.In center of each machine structural allograft, bone type cage was placed, bmp to help stimulate anterior fusion.Now disk spaces between t12-l1, l1-2 and l2-3 were visualized.At l2-3 osteophytes were removed.A small stature femoral ring allograft cage between t12 and l1 was placed.On l1-2 level same procedure was reported, allograft cages were filled with rhbmp-2.A left sided retroperitoneal flank approach was performed with access to l5-s1, l4-5 and l3-4 disks.At l5-s1, a full size femoral allograft lordotic ring was placed and filled up with rhbmp-2.Then surgeon proceeded to l4-5 disk space on right side, an eccentric small stature allograft ring, filled up with bmp on right side.Surgeon then entered l3-4 space, where a parallel femoral ring allograft spacer was placed and filled up with infuses.Surgeon then proceeded to decorticate all lamina, facet joints and transverse processes from t8 down to s1.Autologous bone grafting and fusion was performed utilizing bone removed from ribs.Bmp sponge was placed on right side that remained from anterior rhbmp-2.Complication reported was one small pleural leak.Final diagnosis: adult onset progressive scoliosis with right sided coronal imbalance, anterior posterior fusion, anterior fusion, t12 to s1, with interbody allograft cages and infuse, posterior pedicle screw instrumentation, t8 to s1, with bone grafting.On (b)(6) 2007: patient presented with following pre-op diagnosis: infected scoliosis correction wounds after removal of hardware.Patient underwent the following procedure: incision and drainage of previously infected spine wound.Post-op diagnosis: infected spine wound from removal of hardware.

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: 5864115
• MDR Text Key: 51732281
• Report Number: 1030489-2016-02305
• 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: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• 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: 07/18/2016
• 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): Required Intervention