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); 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.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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2009 patient presented with pre-operative diagnosis of low back pain, lumbar radiculopathy and underwent following procedures :l3,l4,l5,s1 laminectomy, bilateral medial facetectomy and foraminotomy; harvesting of spinous processes for packing the bone and posterolateral instrumentation; bilateral transforaminal discectomies l3-4,l4-5,l5-s1; bilateral transforaminal interbody fusion with peek cage at l3-4, staxx xd interbody device at l4-5 and peek interbody devices at l5-s1; bilateral lateral transverse fusion at l3-4,l4-5,l5-s1 after posterior segmental instrumentation l3-4,l4-5,l5-s1 using dynamics mri compatible posterior instrumentation with pedicle screw system; bilateral transverse fusion grafting with cancellous and cortical bone harvested from the spinous processes.Per operative report: the spinous processes of l3, l4, l5 and s1 were all decompressed.This bone was harvested and cleaned and used for posterolateral arthrodesis and packing of cages.Complete l3, l4, l5, s1 laminectomies were performed and decompression was achieved.Using a transforaminal approach, l3-4,l4-5,l5-s1 interspaces were identified.An mri-compatible peek cage filled with autologous bone was placed l3-l4 thus achieving l3-l4 interbody fusion.Then this procedure was repeated at l4-l5.Then using 7x24 mm staxx xd system, 6 wafers were inserted from a transforaminal approach at l4-l5.These were inserted to a final height of 13 mm.Then a peek interbody cage which had been filled with autologous bone was placed from the transforaminal approach at l5-s1 and a left l5-s1 interbody fusion was achieved.Attention was then turned to posterolateral instrumentation in which pedicle screws were placed into l3,l4,l5,s1 pedicles and an mri compatible rod was contoured and locked into position.This procedure was first done on left side followed by right side.Intraoperative x-rays confirmed position of all instrumentation.Then rhbmp-2/acs was mixed with cancellous and cortical bone harvested from the spinous processes.The bone marrow aspirate was also placed in the lateral gutters for posterolateral arthrodesis at l3-4, l4-5 and l5-s1.Connectors were placed at l4-5 and l3-4.Patient tolerated the procedure without any difficulty.Posteoperatively patient was diagnosed with lumbar radiculopathy for which,he underwent revision surgery on (b)(6) 2010.

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: 6629018
• MDR Text Key: 77234472
• Report Number: 1030489-2017-01478
• 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: 05/15/2017

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: 02/01/2012
• Device Catalogue Number: 7510800
• Device Lot Number: M110810AAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/09/2017
• Supplement Dates Manufacturer Received: 05/15/2017
• Supplement Dates FDA Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2009
• 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; Required Intervention