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 Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).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.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 presented with following pre-op diagnosis: lumbar spinal stenosis (724.02).Lumbosacral disk degeneration (722.52).Lumbar spondylosis (721.3).Post laminectomy syndrome, lumbar (722.83).The patient underwent following procedures: l5-s1 laminectomy with bilateral partial facetectomies and foraminotomies with decompression of the neural elements.Revision, right l4-5 hemilaminectomy with partial facetectomy and foraminotomy with decompression of the neural elements.Revision, left l4-5 hemilaminectomy, partial facetectomy, and foraminotomy with decompression of the neural elements.Revision, right l3-4 hemilaminectomy with partial facetectomy and foraminotomy with decompression of the neural elements.Removal of l3-l5 posterior segmental spinal instrumentation.Exploration of l3-4 and l4-5 posterior spinal fusion.Posterolateral spinal fusion, l3-4.Posterolateral spinal fusion, l4-5.Posterolateral spinal fusion, l5-s1.L3-s1 segmental spinal instrumentation (titanium instrumentation from nuvasive).Local autograft bone graft harvest in preparation for spinal fusion.Morselized allograft bone graft for spinal fusion.Use of rhbmp-2.Spinal monitoring.As per operative notes,¿ the patient's remaining transverse processes at l3, l4, and l5 were decorticated with the bur bilaterally and the lateral fusion mass was also decorticated with the bur at l3-4, l4-5; and the sacral ala were decorticated bilaterally; and the l5-s1 facets were decorticated and destroyed.Rhbmp-2 and morselized allograft bone graft were then applied in bilateral posterolateral gutters across and between the transverse processes of l3, l4, l5, and the sacral ala - first on the left and then on the right.¿ no intra-operative 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7677817
• MDR Text Key: 113742013
• Report Number: 1030489-2018-00981
• 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: 10/04/2018

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: 7510800
• Device Lot Number: M110808AAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2009
• 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