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

Catalog Number	6972660
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	04/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging study were returned to the manufacturer for evaluation.Therefore, we were unable to determine a definitive root cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on (b)(6) 2017, the patient underwent cervical arthroplasty at c5-c6 due to radiculopathy.On an unknown date, around 6 weeks post-operatively, swallowing difficulties were experienced by the patient.It was found that the implant was placed too proud.Hence, on (b)(6) 2019, a revision surgery was performed and the disc replacement surgery was converted to single level anterior cervical discectomy and fusion.The artificial disc was explanted in this revision surgery and was replaced by cage and screws.

• 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: 8735697
• Report Number: 1030489-2019-00667
• Device Sequence Number: 16804062
• Product Code: MJO
• UDI-Device Identifier: 00613994493668
• UDI-Public: 00613994493668
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P090029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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 Catalogue Number: 6972660
• Device Lot Number: 070290W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 06/26/2019
• 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: Required Intervention
• Patient Age: 45 YR
• Patient Weight: 61