MAUDE Adverse Event Report: WARSAW ORTHOPEDICS PRESTIGE CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number	6961460
Medical Device Problem Code	Component Falling (1105)
Health Effect - Clinical Codes	Unspecified Infection (1930); Neck Pain (2433); Neck Stiffness (2434)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.X-ray review result: a single lateral x-ray is provided after c5-6 artificial disc replacement.This x-ray is from 2008.In 2018, the patient suffered esophageal erosion to the implant.Current x-ray would be helpful in finding if there is a portion of the implant which may have contributed to the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Levels implanted: c5-c6 prior surgeries: discectomy of l5 s1 in 2005, a fusion of c2-c3 done in 2006.It was reported by patient that on an unknown date, post-op, from 2009 the patient is suffering with neck problems along with earlier the lower back pain.On (b)(6) 2018, the patient was having problem swallowing and eating so his wife took him to the hospital.The ent there told him that they might have to operate on his neck because she thought the disc was falling apart and causing the pain and the problems swallowing.As reported, the patient neck was huge and extremely red and he was hot to the touch.The ent recommended patient to go home and come back on (b)(6) which the patient did.She drew blood and was working on the treatment plan while the patient was heading home.Patient received a call from ent doctor telling that patient had to get to the hospital as quickly as possible.The ent confirmed that she had opened the patient and found an infection in the area of the artificial disc.She had pulled out approximately 8 cc of infected pus around the disc and noted that she found something similar to coffee grounds in this area too.The patient released from the hospital on (b)(6) 2018 and returned home.The hospital has installed a picc line in patient's arm so he can deliver antibiotics to himself for the next six weeks.They are hoping that this will kill the infection and then they can go ahead and remove and replace all hardware.Patient had not been feeling well for a week or more, and had a very sensitive spot in his neck area that hurt to even touch.Evidently he had some sort of infection at the site near the site of the implanted disc and is currently receiving iv antibody therapy through a picc line.The device itself is intact, but has esophageal erosion near the implant.He is not aware of how long he had the infection before it was detected.He is not aware of where the infection came from.

• Brand Name: PRESTIGE CERVICAL DISC SYSTEM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 7517462
• Report Number: 1030489-2018-00684
• Device Sequence Number: 1439013
• Product Code: MJO
• UDI-Device Identifier: 00613994129215
• UDI-Public: 00613994129215
• Combination Product (Y/N): N
• PMA/510(K) Number: P060018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/16/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2013
• Device Catalogue Number: 6961460
• Device Lot Number: W07M2006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention