MAUDE Adverse Event Report: NUVASIVE, INC. SIMPLIFY® CERVICAL ARTIFICIAL DISC; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	MD-4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted device has been sent to a third party lab for analysis.Upon completion of this analysis and investigation, a supplemental report will be submitted.Label review: "cervical artificial disc risks: failure to relieve symptoms including unresolved pain." "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.".
Event or Problem Description
Approximately 4.5 months after implantation at level c5/6, a simplify disc was removed after the patient did not experience relief of unidentified symptoms related to degenerative disc disease.No device problem or damage was noted upon removal.There were no reported complications during the removal surgery and no further adverse patient impact was reported.No additional information is available.
Additional Manufacturer Narrative
The device was returned and evaluated by a third party lab for june 24, 2022 but no product problem was confirmed.Examination of the device found minor scratches, scrapes and gouging of the polymeric components as well as visible loss of portions of the titanium coating and surface features on the polymeric components considered iatrogenic damage incurred at the time of explantation.Additionally noted deformation consistent with a device implanted for a moderate period of time (4.5 months) where burnishing is consistent with run-in of a well functioning bearing couple, no evidence of catastrophic implant failure or malposition, no product problem could be identified.Review of radiographs provided identified a one-level simplify ctdr.Implant and appears to be in good position without evidence of migration, boney changes, osteolysis or subsidence.The root cause of the required revision appears to be the result of residual pathology pain at the operative c5/6 level and related to the patient condition.No additional investigation can be completed.Review of the device history record notes no material non-conformance, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling review: ".Correct selection of the appropriate implant size and correct placement of simplify cervical artificial disc are essential to ensure proper performance and functioning of the device.Information regarding implant size selection and correct implant placement is provided in this surgical technique guide." ".Simplify cervical artificial disc should only be used by surgeons who are experienced with anterior cervical spinal procedures and have undergone hands-on training in the use of this device.Only surgeons who are familiar with simplify cervical artificial disc components, instruments, procedure, clinical applications, biomechanics, adverse events, and risks associated with simplify cervical artificial disc should use this device.A lack of adequate experience and/ or training may lead to a higher incidence of adverse events, including neurological complications." ".Risks associated with anterior cervical spine surgery: anterior cervical surgical risks are, but may not be limited to: injury or damage to the surgery site area.This includes the nerves, blood vessels, spinal cord, partial paralysis or arm numbness, tingling, or weakness." ".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® CERVICAL ARTIFICIAL DISC
• Common Device Name: PROSTHESIS, INTERVERTEBRAL 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: 15019551
• Report Number: 2031966-2022-00125
• Device Sequence Number: 6857295
• Product Code: MJO
• UDI-Device Identifier: 00843285100054
• UDI-Public: 843285100054
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P200022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 02/28/2025
• Device Model Number: MD-4
• Device Lot Number: 4164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 76 KG