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

Model Number	1181855P2
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Unspecified Nervous System Problem (4426)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is unavailable for evaluation.The root cause cannot be determined at this time.A supplemental report will be submitted upon receipt of additional information to support this investigation.
Event or Problem Description
It was reported that on (b)(6) 2022(?) the patient underwent spinal cage insertion using the xlif method between the third and fifth lumbar vertebrae, followed by vertebral fusion surgery between the third and fifth lumbar vertebrae.Then on (b)(6) 2026 our sales representative visited the medical institution for a postoperative follow-up and received a report that the patient had developed neurological symptoms.The surgeon suggested that the shim may have shifted posteriorly during traction device placement.

• Brand Name: MODULUS
• 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 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 24866326
• Report Number: 2031966-2026-00051
• Device Sequence Number: 9271365
• Product Code: MAX
• UDI-Device Identifier: 00887517726063
• UDI-Public: 887517726063
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: 1181855P2
• 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: 03/17/2026
• Initial Report FDA Received Date: 04/13/2026
• 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: Other
• Patient Sex: Unknown