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

Catalog Number	6972860
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Stenosis (2263)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.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
Procedure used in initial surgery: anterior cervical disc arthroplasty (acda) removal c5/6 preoperative diagnosis for revision: end stage spondylosis with foraminal stenosis procedure used in revision: anterior cervical discectomy and fusion (acdf) c3-c7 it was reported that the patient underwent an acda at c5-6.Post-op, patient suffered with end stage spondylosis with foraminal stenosis.As a result, patient underwent an acdf with extension from c3-7.Revision surgery had no issues and went as planned.
Additional Manufacturer Narrative
Product analysis received from third party: evidence of macroscopic wear was found on both components primarily localized to the wear scar region of both articulating surfaces.The superior and inferior components had wear patterns consistent with impingement.The components also had evidence of iatrogenic damage.The observations of bio-films on the end plates represent a finding and is typically observed on these type of explants.Biofilms are commonly observed on metal-on-metal hip replacement components, although such implants are manufactured from a different alloy.Based on these observations, and the short implantation time, further analysis (sem and micro ct analysis) is not expected to further the understanding of how the cervical disc replacement performs clinically.If information is provided in the future, a supplemental report will be issued.

• 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: 8132006
• Report Number: 1030489-2018-01603
• Device Sequence Number: 19262727
• Product Code: MJO
• UDI-Device Identifier: 00613994493637
• UDI-Public: 00613994493637
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P090029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2022
• Device Catalogue Number: 6972860
• Device Lot Number: 0326268W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 04/02/2019
• 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: Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 91