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

Catalog Number 7510400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neuropathy (1983); Tingling (2171); Ambulation Difficulties (2544); Weight Changes (2607)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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.Products from multiple manufacturers 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) 2009, the patient underwent spine fusion surgery on the lumbar region of her spine from vertebrae l4 to l5 wherein rhbmp-2/acs was implanted from a posterior approach in the posterolateral elements.Post-op, the patient had increasing low back and right leg pain, with associated numbness and tingling.She had undergone spinal injections and implantation of a spinal cord stimulator.However, she continued to experience constant and extreme lower back pain, radiating to her hips and legs, and numbness/ tingling in her hips, legs and feet.She experienced difficulty sitting and standing for extended periods of time.She required the assistance of a motorized wheelchair when leaving her home.She also suffers from depression and weight gain due to her pain and physical limitations.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that on: (b)(6) 2009, the patient was pre-operatively diagnosed with foraminal stenosis and segmental instability with spondylolisthesis l4-5, severe degenerative facet disease l4-5 with intractable lumbar pain and leg pain.The patient underwent the following procedures: bilateral lumbar laminectomy l4-5.Posterior spinal fusion with bone morphogenic protein and mosaic l4-5.Spinal instrumentation with monarch instrumentation at l4-5.As per op-notes, ¿the corners of the facet of l3-4 and l4-5 were removed.The pedicle probes were placed in the pedicles of l4 and 5, tapped to 6mm.Bone was sounded and felt on all sides.Wax was placed in the anterior holes for later use.The surgeon then performed the bilateral lumbar laminectomy.After the laminectomy was completed, the posterolateral elements were decorticated with the high speed drill.Bone morphogenic protein and mosaic were packed in the posterotateral elements.Then 7 by 35 mm monarch screws were placed in the pedicles of l4 and l5.¿ no complications were reported.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5546543
• MDR Text Key: 41817569
• Report Number: 1030489-2016-00923
• 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,Followup
• Report Date: 09/11/2017

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
• Device Expiration Date: 09/01/2011
• Device Catalogue Number: 7510400
• Device Lot Number: M110803AAN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: 03/10/2016; 09/11/2017
• Supplement Dates FDA Received: 09/20/2017; 09/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2009
• 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