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

Catalog Number	6972470
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
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 arthroplasty at c5-6 due to degenerative disc disease.Post-op, the implanted device (graft) had subsided into the body of c6 due to crushed body of c6 and end plate.The patient suffered much neck pain due to this and underwent removal surgery.The device was removed and then a corpectomy was done at c6.
Additional Manufacturer Narrative
Product analysis results: evidence of macroscopic wear on both component primarily localized to the wear scar region of both articulating surfaces.The superior and inferior components showed wear patterns consistent with impingement.The observations of biofilms on the endplates represent a finding and is typically observed on prestige 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 are 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 prestige cervical disc replacement performs clinically.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Op-notes: there is evidence of displacement of the inferior aspect of the artificial disc into the c6 vertebral body through the superior endplate causing deformation of the c6 body and impingement of the artificial disc within the vertebral body itself.The surgical field exposure then was completed to encompass the c5-7 levels as there was no way around performing a c6 corpectomy in order to retrieve the artificial disc and decompress the spinal cord/nerves.The artificial disc was then removed and sent for corporate retrieval and quality control evaluation.The corpectomy at c6 was completed.This bone was used for autograft re-implantation.Good decompression of the spinal cord and nerve roots was obtained.

• 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: 8334436
• Report Number: 1030489-2019-00135
• Device Sequence Number: 70679
• Product Code: MJO
• UDI-Device Identifier: 00613994493699
• UDI-Public: 00613994493699
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P090029
• 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): 05/24/2019

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: 02/21/2026
• Device Catalogue Number: 6972470
• Device Lot Number: 0631943W
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/19/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 05/24/2019
• 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 Weight: 108