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

Catalog Number 7510200

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

Patient Problems Neuropathy (1983); Pain (1994); Swelling (2091); Tingling (2171); Numbness (2415); Ambulation Difficulties (2544)

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.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) 2011, the patient underwent a spinal fusion surgery on the lumbar region of his spine from vertebrae l5 to s1.Reportedly, during the surgery, rhbmp-2/acs was used in the patient.It was also reported that the rhbmp-2 collagen sponge was placed outside a cage (i.E., in the posterolateral gutters).As reported, the patient's post-operative period had been marked by a period of improvement, followed by a progressive return of low back pain and radiculopathy into his lower extremities.Patient continues to experience constant low back pain, with pain, numbness and tingling in both legs, and periodic swelling in his back.Patient suffers from nerve damage and bladder issues, and has difficulty standing and walking.These serious injuries prevent patient from practicing and enjoying the activities of daily life that patient enjoyed pre-operatively.

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

The patient was pre-operatively diagnosed with: severe lumbar stenosis.Lateral recess stenosis, l5-s1.History of lumbar spondylolisthesis, l5-s1.He underwent the following procedures: l5-s1 decompressive laminectomy/foraminotomy.Pedicle screw stabilization, l5-s1.Posterolateral arthrodesis using bmp- containing sponges, local autograft, and mosaic bone graft extender.As per op-notes, "the pedicle screws were then connected with titanium rods and a crosslink, and fluoroscopy was used to confirm proper placement of the pedicle screws.The construct was then tied into the appropriate torque.Epidural catheter was placed.The wound was then irrigated with 3 l of bacitracin-containing solution.The degenerative processes were decorticated, and then bmp-containing sponges with local allograft were then placed in the posterolateral gutters; this was also mixed with the mosaic bone graft extender.A medication hemovac drain was placed.Hemostasis was established in a meticulous fashion using bovie cautery.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: 5549664
• MDR Text Key: 41937421
• Report Number: 1030489-2016-00957
• 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: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510200
• Device Lot Number: M110911AAJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2010
• 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