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

Catalog Number	6972260
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Paralysis (1997)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on an unknown date, patient presented with degenerative disc disease and stenosis; and underwent a surgery at c5-c6 and c6-c7 using discs, rods, screws and plates.Post-op,the patient had vocal cord paralysis.According to the surgeon, the patient was not improving with arthroplasty device.It was also alleged by the patient that the disc was installed wrong.Hence, on (b)(6) 2019, a revision surgery was performed, in which the surgeon explanted the discs; and the procedure was converted to fusion.Decompression was also performed during this surgery.No patient complications have been reported currently.

• 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: 9521558
• Report Number: 1030489-2019-01487
• Device Sequence Number: 18961914
• Product Code: MJO
• UDI-Device Identifier: 00613994493736
• UDI-Public: 00613994493736
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P090029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/26/2019

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 Expiration Date: 02/11/2024
• Device Catalogue Number: 6972260
• Device Lot Number: 0458214W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/26/2019
• 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: 60 YR