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

Catalog Number 7510800

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

Patient Problems Neuropathy (1983); Stenosis (2263)

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 presented with adult idiopathic scoliosis and lumbar spinal stenosis.The patient underwent anterior spinal fusion l3 to s1 with cage, rhbmp-2 and allograft bone.As per op-notes, ¿¿.Trials were placed at each disk space and at l5-s1 and at l4-l5 a 10 x 14-nun trial was appropriate, and at l3-l4 an 8 x 12-mm trial was selected.Cages of these sizes were then selected, filled with crushed cancellous allograft and rhbmp-2, and impacted into the disk spaces at l5-s1 then l4-ls, then l3-l4 at the above-mentioned sizes.¿.¿ no patient complications were reported.The patient also underwent anterior approach to l3 through s1 through a retroperitoneal dissection.On (b)(6) 2011, the patient presented with l4 and ls lumbar spinal stenosis with neurogenic claudication and bilateral lower extremity radiculopathy.The patient underwent ls, l4, and partial l3 laminectomies with medial facetectomies and foraminotomies.Also the patient presented with adult scoliosis and lumbar spinal stenosis and underwent removal, battery pack, spinal cord stimulator; and posterior spinal fusion, t3 to s1 with instrumentation, iliac fixation, and right iliac crest bone graft.No patient complications were reported.

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: 6130985
• MDR Text Key: 60989772
• Report Number: 1030489-2016-03291
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843829
• UDI-Public: 00681490843829
• 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: 11/07/2016

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: 09/01/2013
• Device Catalogue Number: 7510800
• Device Lot Number: M111054AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: 11/07/2016
• Supplement Dates FDA Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2011
• 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: 54 YR