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 Code	Osteolysis (2377)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device malfunction was alleged and remains in-situ, radiographs provided confirm the reported event.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
It was reported that a simplify implant had osteolysis.
Additional Manufacturer Narrative
The investigation reveals that the complaint relates to a nuvasive simplify disc size 1, height 4.The report indicates that, at about 30 months post-op, the disc had subsided into the vertebral bodies.The patient was revised to an acdf construct on (b)(6)2025.No product was provided for evaluation.A post-operative radiograph of the reported issue was provided and the complaint was confirmed.Operative notes were not provided for review of usage/technique.Information regarding the patient's bone quality/bone density was not provided for review.The root cause of the issue was unable to be determined with the information provided; however, it may have been caused by an infection as it was reported the patient tested positive for cutibacterium, and surgeon suspects that is the reasoning for osteolysis.Labeling, and complaint history reviews were completed with no deficiencies, discrepancies, or adverse trends identified.Complaint monitoring will continue and additional action will be taken in the event that an adverse trend is identified.No additional action is planned at this time.
Event or Problem Description
It was reported that a simplify implant had osteolysis.

• Brand Name: SIMPLIFY® CERVICAL ARTIFICIAL DISC
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 22902392
• Report Number: 2031966-2025-00114
• Device Sequence Number: 12974659
• Product Code: MJO
• UDI-Device Identifier: 00843285100009
• UDI-Public: 00843285100009
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P200022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: SM-4
• Device Catalogue Number: SM-4
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Race: White