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 Dysphagia/ Odynophagia (1815); Dyspnea (1816); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Numbness (2415); Neck Pain (2433)

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.Note: multiple product were 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.

Event Description

It was reported that the patient underwent two spinal fusion surgeries using rhbmp-2/ acs in a posterolateral thoracolumbar fusion surgery and a posterior cervical fusion surgery.On (b)(6) 2006, patient underwent the first spinal fusion surgery at t4-l2 levels of her vertebrae.The rhbmp-2 was used to fuse more than one level of the spine using posterior approach.The rhbmp-2 collagen sponge was placed outside a cage in the posterior elements.On (b)(6) 2008, patient underwent second spinal fusion surgery on the cervical region of her spine from vertebrae c2 to c5.The rhbmp-2 collagen sponge was used to fuse more than one level of the spine using posterior approach.The rhbmp-2 collagen sponge was placed outside a cage.Patient's post-operative period was marked by initial improvement, followed by increasingly severe and chronic neck pain, with pain radiating up to her head and down to her shoulders pain, limited range of motion of her neck and arms, and numbness of her fingertips on her left hand.She experiences difficulty speaking, swallowing, and breathing.These serious injuries prevented patient from practicing and enjoying the activities of daily life that she enjoyed pre-operatively.

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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5537303
• MDR Text Key: 41517828
• Report Number: 1030489-2016-00855
• 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
• Report Date: 03/10/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 03/31/2016
• Supplement Dates Manufacturer Received: 03/10/2016
• Supplement Dates FDA Received: 09/20/2017
• 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): Other