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

Model Number	SM-4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Neck Pain (2433)
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
It was reported the patient continued to experience neck and trapezius pain after a simplify disc index procedure at c4/5.As a result, the simplify disc was removed approximately 2.5 months after implantation.During removal surgery, no implant migration was noted, when compared to immediate post-op films from the index procedure, and the device was found intact with no observable disruption to surrounding tissue.There were no complications during device removal.No further patient adverse impact was reported.
Event or Problem Description
New or updated information found in section h10.
Additional Manufacturer Narrative
The explanted device was returned for evaluation but no radiographs were provided and the complaint could not be confirmed.Though no product malfunction was reported the explanted disc was sent to a third party lab for analysis where ex-plant examination discovered minor iatrogenic damage and deformation on the articulating surfaces expected and considered normal micro-abrasive wear associated with 2.5 months of in-vivo usage and removal process, which supports run-in a well functioning bearing couple.No evidence of catastrophic implant failure, migration or disruptions to the surrounding tissues.Due to a lack of information provided a definitive root cause could not be determined though the patients residual stenosis or herniated nucleus pulposus, implant sizing, implant positioning, intra-operative implant subsidence due to technique are suspected as the likely cause or contributors.No additional investigation can be completed.Label 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." "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® 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: 13573630
• Report Number: 2031966-2022-00044
• Device Sequence Number: 5706496
• Product Code: MJO
• UDI-Device Identifier: 00843285100009
• UDI-Public: 843285100009
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P200022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/19/2022

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: 06/30/2025
• Device Model Number: SM-4
• Device Lot Number: 4292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/26/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female