MAUDE Adverse Event Report: NUVASIVE, INC SIMPLIFY DISC

Model Number	57015-B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Stenosis (2263)
Date of Event	07/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Explant of ide subject 03-601 c/cdj (ide# 03-301 c).Implantation at cervical level c6/c7.Reason for the explant is recurrent stenosis with failed injection relief and severe radiculopathy.
Event or Problem Description
An ide subject was implanted with a simplify disc at level c6/7.Approximately 64 months after implantation, the device was explanted due to the patient experiencing recurrent stenosis with failed injection relief, and severe radiculopathy.During the removal procedure, no subsidence or device damage or malfunction was found.This is a supplemental report for a previous adverse report (3012070713-2021-00004).
Additional Manufacturer Narrative
The explanted disc, radiographs and tissue samples were provided and the complaint was confirmed.A definitive cause of the reported pain, stenosis and adjacent segment herniations cannot be determined though review of all provided information suggests it may be the result of patient anatomical factors/continuation of pathology, patient post-op physical activities, and/or positioning during the index procedure.No product malfunction was alleged or identified.Production record review: review of the device history records notes no material non-conformances, no manufacturing errors, and no discrepancies with respect to material type, treatments, and dimensions that may have caused or contributed to the reported event.Parts met acceptance criteria upon release.Labeling review: ".Cervical artificial disc risks:.Failure to relieve symptoms including unresolved pain.Development of spinal conditions, including but not limited to spinal stenosis, spondylolisthesis, or retrolisthesis." ".Patients should be instructed in postoperative care procedures and should be advised of the importance of adhering to these procedures for successful treatment with the device.Heavy lifting (greater than 20lbs) should be avoided for 6 weeks, and impact sports should be avoided for 3 months." ".Patient selection is extremely important.In selecting patients for a total disc replacement, the following factors can be of extreme importance to the success of the procedure: the patient's occupation or activity level; a condition of senility, mental illness, alcoholism or drug abuse; certain degenerative diseases that may be so advanced at the time of implantation that the expected useful life of the device is substantially decreased, and medical conditions that may affect postoperative management, such as alzheimer's disease and emphysema." ".Preoperative planning may be used to estimate the required implant size and to assure that the appropriate range of sizes is available for surgery.Correct selection of the appropriate implant sizes is extremely important to assure the placement and function of the disc.The procedure should not take place if the appropriate range of sizes are not available." ".Potential adverse effects of device on health: below is a list of the potential adverse effects (e.G., complications) identified from the simplify® cervical artificial disc clinical study results, approved device labeling for other cervical total disc replacement devices, and published scientific literature including: (1) those associated with any general surgical procedure; (2) those associated with anterior cervical spine surgery; and (3) those associated with a cervical artificial disc device, including the simplify® cervical artificial disc.In addition to the risks listed below, there is also the risk that surgery may not be effective in relieving symptoms or may cause worsening of symptoms.Additional surgery may be required to correct some of the adverse effects.".

• Brand Name: SIMPLIFY DISC
• Common Device Name: SIMPLIFY DISC
• Manufacturer (Section D): NUVASIVE, INC; 7475 lusk blvd.; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer Contact: geoffrey gannon ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 12320964
• Report Number: 3012070713-2021-00004
• Device Sequence Number: 19960165
• Product Code: MJO
• UDI-Device Identifier: 00843285102133
• UDI-Public: 843285102133
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P200022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

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: 11/01/2017
• Device Model Number: 57015-B
• Device Catalogue Number: 3-5L
• Device Lot Number: 2880
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male