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); Dysphagia/ Odynophagia (1815); Pain (1994)

Event Type  Injury  

Event Description

It was reported in an online article that in 2010, the patient underwent two neck surgeries, both with rhbmp-2/acs.The patient's doctor reportedly explained that he had one ruptured disc.Per the patient, ¿just a few months after the first surgery, i needed another one because the disc above or below was bad,¿ ¿i thought the first surgery fused the vertebrae but i think this bone graft caused damage to the next disc.I went back to the surgeon again.He told me that bone was growing outside the infuse bone graft but there was no reason to do more surgery.Before having this surgery, i understood that the graft was going to contain everything but this isn¿t the case with me.¿ the patient reports that he isn¿t sure why his surgeon said it was okay or why bone is growing outside the graft.He is on disability due to a back injury at work and can¿t afford the cost of co-pay to see another doctor.Per the patient, ¿i¿ve had problems swallowing for some time and it¿s getting worse.Now that i think about it, this problem started not long after the surgery.It happens sometimes when i eat dinner and when i eat too fast.If i am stressed, it bothers me too.It scares me when i get this swallowing problem with food because i think that i am going to choke.It is especially worrisome when i am by myself.When it happens, it is hard not to panic - imagine having a golf ball stuck in your throat.That¿s what it feels like.¿ the patient also reports that he is in constant pain, from his neck and throat and into his shoulders.

Manufacturer Narrative

Article citation: mundy, jane."medtronic double-dipping?" lawyers and settlements.Online legal media, 23 march 2015.Web.27 march 2015.<(>< <)>http://www.Lawyersandsettlements.Com/articles/medtronic-infuse-bone-graft/interview-medtronic-lawsuit-bone-graft-16-20530.Html>.2010.(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.Products from multiple manufacturers 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.

• 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: 4693967
• MDR Text Key: 22248208
• Report Number: 1030489-2015-00791
• 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: Other
• Type of Report: Initial
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• 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: 03/24/2015
• 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): Required Intervention
• Patient Age: 00046 YR