MAUDE Adverse Event Report: NUVASIVE, INC. SIMPLIFY; CERVICAL TOTAL INTERVERTEBRAL DISC PROSTHESIS, MODULAR

Model Number	3-5L-CE
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	07/23/2026
Type of Reportable Event	Malfunction

• Brand Name: SIMPLIFY
• Common Device Name: CERVICAL TOTAL INTERVERTEBRAL DISC PROSTHESIS, MODULAR
• 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: 25846392
• Report Number: 2031966-2026-00089
• Device Sequence Number: 16028345
• Product Code: MJO
• UDI-Device Identifier: 00843285102133
• UDI-Public: 843285102133
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P200022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3-5L-CE
• Device Lot Number: 2880B
• 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: 06/23/2026
• Initial Report FDA Received Date: 07/16/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 84 KG