MAUDE Adverse Event Report: NUVASIVE, INC. MODULUS EXPANDABLE; METALLIC SPINAL INTERBODY FUSION CAGE

Model Number	1939928P2
Medical Device Problem Codes	Unintended System Motion (1430); Implant subsidence (4078)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a mod-ex cage has lost height post operatively.
Additional Manufacturer Narrative
The device has not returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.

• Brand Name: MODULUS EXPANDABLE
• Common Device Name: METALLIC SPINAL INTERBODY FUSION CAGE
• 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: 22992456
• Report Number: 2031966-2025-00118
• Device Sequence Number: 8997595
• Product Code: MAX
• UDI-Device Identifier: 00195377056429
• UDI-Public: 195377056429
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K210214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 05/29/2026

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: 1939928P2
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 05/29/2026
• 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
• Patient Sex: Unknown