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 Problems Incontinence (1928); Pain (1994); Numbness (2415)

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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2013, the patient was preoperatively diagnosed with 1.Degenerative scoliosis.2.Lumbar stenosis with neurogenic claudication.3.Coronal imbalance and underwent the following procedures: 1.Posterior instrumentation t3, t4, t5, t6, t7, t8, t9, t10, t11, t12, l1,l2, l3, l4, l5.2.Posterior instrumented fusion t3-4, t4-5, t5-6, t6-7, t7-8, t8-9, t9-10, t10-11, t11-12, t12-l1, l1-2, l2-3, l3-4, l4-5.3.Placement of iliac bolt.4.Lumbar laminectomy l4, l5.5.Placement and removal of tongs.6.Use of local autograft bone.7.Use of allograft bone.8.Intraoperative of fluoroscopy.9.Placement of bilateral skeletal traction.10.Use of bone marrow aspirate.As per the op notes: ¿we also derotated the spines, first starting on the concave side and then convex side.We decorticated all of our bony surfaces and placed large kit and a medium kit of bone morphogenic protein, which the patient was preoperatively consented for and we discussed the risks, benefits and alternatives of bone morphogenic protein, as part of the preoperative visit.We then placed 150 cc of crushed cancellous bone mixed with local autograft bone that had been collected.We also mixed this with bone marrow aspirate.¿ the patient tolerated the procedure well without any intraoperative complications.Reportedly, rhbmp-2/acs was used in this surgery.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the posterior elements).Post-op, the patient suffered from increasing low back pain, burning leg pain, left thigh and groin pain when standing, numbness in his feet, and weakness in his left leg.Severe pain and symptoms ultimately compelled patient to undergo three risky, painful and costly revision surgeries on (b)(6) 2015.Despite these revision surgeries, patient continued to experience constant and severe lower back pain, with pain radiating to his right hip and down his right leg, and burning and stabbing pain in his mid and upper back.He also suffers from urinary incontinence.Patient experienced difficulty getting up from a seated position, standing, and walking, and requires the use of a walker to ambulate and a wheelchair for any extended distances.These serious injuries prevent patient from practicing and enjoying the activities of daily life.

• 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: 7006647
• MDR Text Key: 91245787
• Report Number: 1030489-2017-02278
• Device Sequence Number: 1
• Product Code: NEK
• UDI-Device Identifier: 00681490843805
• UDI-Public: 00681490843805
• 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
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2015
• Device Catalogue Number: 7510400
• Device Lot Number: M111201AAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2013
• 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): Required Intervention