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 Problem No Code Available (3191)

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 (b)(6) 2009 the patient was pre-operatively diagnosed with spondylolisthesis, l4-5, grade two.Foraminal stenosis, l4-5, severe bilaterally.Lumbar radiculopathy and underwent the following procedures: bilateral complete laminectomy, l4-5 including completing facetectomy, l4-5 bilaterally for decompression of the thecal sac and roots.Complete discectomy at l4-5.Posterior lumbar interbody arthrodesis at l4-5 using a modular peek spacer, interbody device packed with bone morphogenic protein.Open reduction of spondylolisthesis.Posterior instrumented fusion l4-5, using the screw system.Posterolateral arthrodesis l4-5 using morselized autograft as well as with constituted bone morphogenic protein.Harvesting of morselized autograft via the same incision.As per the op-notes: ¿a 10mm x 20mm x 0 degree modular peek spacer was selected.This was the packed full of allograft that had been reconstituted with bone morphogenic protein¿.A high speed drill was used to decorticate the transverse processes of l4 and l5 bilaterally and a posterolateral arthrodesis was accomplished using morselized autograft, as well as the remaining vitoss ba reconstituted bone morphogenic protein.¿ post operatively the patient reported back pain and underwent a revision surgery in (b)(6) 2014.

Manufacturer Narrative

Additional information.

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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6649458
• MDR Text Key: 77823138
• Report Number: 1030489-2017-01593
• 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: 05/22/2017

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 Catalogue Number: 7510400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/19/2017
• Supplement Dates Manufacturer Received: Not provided; 05/22/2017
• Supplement Dates FDA Received: 06/21/2017; 10/04/2017
• 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
• Patient Age: 45 YR