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

Model Number	2-5L-CE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Stenosis (2263); Numbness (2415); Neck Pain (2433)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received via clinical study that approximately 60 months after an index procedure at c3/4, the patient experienced stenosis at levels c3 to t2 with myelopathy, left and right arm pain, numbness, and weakness, axial neck pain, and bilateral foraminal stenosis at levels c5 to t1.Treatment included posterior cervical decompression and fixation from c3 to t2.The patient has reportedly recovered.
Additional Manufacturer Narrative
No device was returned as the device remains in-situ and no product malfunction was suggested.The patient's medical history and comorbidities, and activity level are unknown.A definitive cause of the reported conditions cannot be determined but could be related to patient selection, patient medical conditions/comorbidities, and/or patient activity level.The patient reportedly has recovered after posterior cervical decompression and fixation.Manufacturing records were reviewed and found the lot met all acceptance criteria upon release.There were no non-conformances, discrepancies, or other manufacturing issues related to the reported event.Labeling review: ".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 (aes), 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 aes, including neurological complications." ".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." ".Anterior cervical surgical risks are, but may not be limited to:.Arm weakness or numbness." ".Risks specific to cervical artificial discs, including the simplify® cervical artificial disc, are but may not be limited to.Nerve injury, paralysis or weakness that is temporary or permanent, failure to relieve symptoms including unresolved pain, spinal cord damage, development of spinal conditions including but not limited to spinal stenosis, spondylolisthesis, or retrolisthesis, removal, revision, reoperation or supplemental fixation of the disc." should additional information become available, a supplemental report will be submitted.

• Brand Name: SIMPLIFY® CERVICAL ARTIFICIAL DISC
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 13773365
• Report Number: 2031966-2022-00060
• Device Sequence Number: 3812808
• Product Code: MJO
• UDI-Device Identifier: 00843285101990
• UDI-Public: 843285101990
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P200022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2022

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: 12/01/2019
• Device Model Number: 2-5L-CE
• Device Lot Number: 2909
• Was Device Available for Evaluation?: No
• 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: 02/22/2022
• Initial Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2016
• 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 Sex: Prefer Not To Disclose