MAUDE Adverse Event Report: NUVASIVE INC. SIMPLIFY CERVICAL ARTIFICIAL DISC; PROTHESIS INTERVERTEBRAL DISC

Model Number	MD-5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned directly to a third party lab for evaluation which has not yet concluded.Should more information be gleaned from the third party lab evaluation an additional report will be filed.At this time due to a lack of information no root cause could be determined at this time although a continuation of pathology, excessive postoperative physical activity, implant selection and placement are possible cause and contributors.Manufacturing review: 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: ".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." "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." ".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." "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." "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." 32226-e-2023-03.
Event or Problem Description
On an unknown date a patient underwent cervical total disc replacement (ctdr) procedure at c6/7 due to neck pain and cervical stenosis.On (b)(6) 2024 the patient reported neck pain and return of pre-operative symptoms and a revision was performed the ctdr at c6/7 was removed without issue and replaced with a standalone fusion device.

• Brand Name: SIMPLIFY CERVICAL ARTIFICIAL DISC
• Common Device Name: PROTHESIS 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: patrick yrigoyen ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 19996457
• Report Number: 2031966-2024-00194
• Device Sequence Number: 15599799
• Product Code: MJO
• UDI-Device Identifier: 00843285100061
• UDI-Public: 843285100061
• 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 Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2024

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 Model Number: MD-5
• Device Lot Number: W85427
• 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: 07/23/2024
• Initial Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2022
• 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: 31 YR
• Patient Sex: Female
• Patient Weight: 60 KG