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

Catalog Number 7510100

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

Patient Problems Dysphagia/ Odynophagia (1815); Headache (1880); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Burning Sensation (2146); Tingling (2171); Injury (2348); Numbness (2415); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Note: 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.Multiple products 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.

Event Description

It was reported that on (b)(6) 2013, the patient underwent posterolateral cervicothoracic fusion surgery on the cervicothoracic region of her spine from vertebrae c5 to t1.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.Post-op, the patient experienced increasing neck pain, headaches, and tingling and burning in her hands.She continues to experience chronic neck pain, with radiating pain into her shoulders, constant tingling and burning in her neck and shoulders, shooting pain down the back of her neck, numbness and tingling in her fingers, difficulty swallowing, and headaches.Patient cannot look down for an extended period of time, and experiences difficulty sleeping.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that the patient was pre-operatively diagnosed with cervical pseudoarthrosis, c5 to t1.C8 radiculopathy and underwent the following procedures: c5 to t1 posterior segmental instrumented fusion with lateral mass and pedicle screws.Posterolateral arthrodesis, c5 to t1, with cortico-cancellous bone and infused rhbmp-2.C7-t1 bilateral lamino-foraminotomy for c8 nerve root decompression bilaterally and discectomy.Application and removal of mayfield cranial tongs.As per op-notes,¿ at c7-t1, a bilateral lamino-foraminotomy was done, removing 10 percent of the lamina and facet complex, decompressing the traversing and exiting c8 nerve root.Foraminotomy at the c8 nerve root was done with a 2 mm kerrison.A diskectomy was done at c7-t1 with the micropituitary removing degenerative fragments at c7-t1.Next, the wound was irrigated with 2 liters of saline, decorticated posterolaterally from c5 to t1, and local lamina bone, cortico-cancellous bone, and an extra small packet of infused rhbmp-2 were placed posterolaterally for an arthrodesis from c5 to t1.A lordotic rod was placed, the set screws were secured and counter torqued.Final ap and lateral images confirmed good hardware position.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: 5744089
• MDR Text Key: 47995324
• Report Number: 1030489-2016-01857
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Catalogue Number: 7510100
• Device Lot Number: M111304AAG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2013
• 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): Other