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

Model Number	67940037P2
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
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 the patient who underwent anterior cervical decompression and fusion surgery.The cage was placed between c4/5 vertebrae in the primary surgery, the fitting was good and the wound was closed.However, the next day the cage had moved forward, and a ct scan taken the following week showed that it had moved even further forward.So, the surgeon removed the cage and inserted new one with plate for fixation.We did not obtain the implant.

• Brand Name: MODULUS
• Common Device Name: POLYMERIC 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: 25151292
• Report Number: 2031966-2026-00069
• Device Sequence Number: 9396667
• Product Code: ODP
• UDI-Device Identifier: 00887517959430
• UDI-Public: 00887517959430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: 67940037P2
• Device Lot Number: N472706
• 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: 05/11/2026
• Initial Report FDA Received Date: 05/12/2026
• 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: Male