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

Catalog Number 6972870

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inadequate Pain Relief (2388); Neck Pain (2433)

Event Type  Injury  

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.Although it is unknown whether this product caused or contributed to the reported event, we are filling this mdr for notification purpose.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent a surgery due to neck pain.In this surgery, the patient was implanted with artificial disk.Post-op, the patient complained of continued neck pain.Hence, a revision surgery was performed wherein the implant was completely removed.Along with implant removal, anterior cervical discectomy and fusion was also performed.

Manufacturer Narrative

Product analysis: evidence of macroscopic wear on both components primarily localized to the wear scar region of both articulating surfaces.The inferior component showed a wear pattern consistent with impingement.The observation 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 the implant are consistent with the damage mechanisms seen in previously analyzed retrievals.Based on these observations and the short implantation time, further analysis (i.E.Sem and microct 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.

Manufacturer Narrative

Additional information: b5 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Pre-operative diagnosis (implant surgery): myeloradiculopathy treated level: c6-c7 reason for explantation: persistent pain surgical site description: scar tissue was present, integrity of device was intact.In the revision surgery, fusion was performed with plate and interbody.

• Brand Name: PRESTIGE CERVICAL DISC SYSTEM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 8703863
• MDR Text Key: 148163970
• Report Number: 1030489-2019-00633
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00613994493620
• UDI-Public: 00613994493620
• Combination Product (y/n): N
• PMA/PMN Number: P090029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 6972870
• Device Lot Number: 0666662W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 12/09/2019; 05/28/2020
• Supplement Dates FDA Received: 01/08/2020; 06/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR