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

Catalog Number	6972650
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/09/2018
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 the patient underwent a surgery in which artificial discs were implanted.From (b)(6) 2018, post-op, the patient started having severe pain.Hence, on (b)(6) 2019, the patient underwent a revision surgery, in which the implant was explanted from c5-c6 level.The implant fractured during the removal process.No fragment of the fractured implant remained inside the patient.Anterior/posterior fusion was also performed at c4-c7 level in this revision surgery.No patient complications have been reported post revision surgery.
Additional Manufacturer Narrative
Product analysis received from third party: evidence of macroscopic wear was observed on both components primarily localized to the wear scar region of both articulating surfaces.The fractures of the superior components for disc occurred during the removal process.The observations of biofilms on the endplates represent a finding and is typically observed on these explants.Biofilms are commonly observed in metal-on-metal hip replacement components, although such implants are manufactured from a different alloy.The damage mechanisms observed on disc is consistent with the damage mechanisms seen in previously analyzed retrievals.Based on these observations, further analysis is not expected to further the understanding of how artificial 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: 8467928
• Report Number: 1030489-2019-00359
• Device Sequence Number: 1341079
• Product Code: MJO
• UDI-Device Identifier: 00613994493675
• UDI-Public: 00613994493675
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P090029/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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: 01/06/2025
• Device Catalogue Number: 6972650
• Device Lot Number: 0537482W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 03/30/2019
• Supplement Report FDA Received Date: 06/06/2019
• 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: 50 YR