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

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

Patient Problems Ossification (1428); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient underwent lumbar spinal fusion at l5-s1 using rhbmp-2/acs with a tlif approach.Reportedly, sometime post-op, the patient developed osteophyte formation in his lumbar spine.The patient experienced severe back pain, nerve damage, male sterility, pain in his legs, and permanent disability.

Manufacturer Narrative

(b)(4).Neither the device nor applicable imaging study films or patient medical records 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/used 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.

Manufacturer Narrative

Add'l info.

Event Description

It was reported that on (b)(6) 2011 the patient underwent, anterior lumbar interbody arthrodesis at l5-s1.Placement of anterior lumbar intervertebral biomechanical device utilizing a peek cage at l5-s1.Posterior lumbar instrumentation s1.Posterior lumbar instrumentation including bilateral iliac fixation.Posterolateral arthrodesis at l5-s1.Posterolateral arthrodesis of spinal iliac.Preoperative diagnosis: lumbosacral instability with segmental kyphosis.As per op note: ¿bone graft was placed including a bone marrow aspirate concentrated with collagen as well as remaining rhbmp-2.Rhbmp-2 placed in the interbody cage placed anteriorly.Intraoperative x ray was taken on three occasions.Following placement of the hardware, positioning and at the final construct was assembling.Final construct was tightened.¿ the patient underwent anterior exposure of l5-s1 for discectomy and fusion.Preoperative diagnosis: lumbar instability at l5-s1.

• 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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4271326
• MDR Text Key: 21174452
• Report Number: 1030489-2014-04527
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2017
• 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): Disability