MAUDE Adverse Event Report: NUVASIVE, INC. MODULUS; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Model Number	67940068P2
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon used 2 spinal cages for anterior cervical discectomy and fusion (acdf).The surgeon informed that the cage had come out forward 2 days after surgery; he should perform surgery again.No other adverse patient consequences were reported.No cages were obtained from the hospital.This event occurred in japan.
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.
Additional Manufacturer Narrative
The investigation revealed that there was a report relating to two (2) modulus cervical, 5x19x16mm 7 (67940068p2) spacers.It was reported that a patient underwent an acdf on (b)(6) 2025.Two (2) days post-operatively, it was reported that a spacer had migrated anteriorly.No additional adverse effects were reported, and the device(s) remain in-situ, however a revision surgery was planned/suggested.No radiographs were provided and the complaint could not be confirmed.Labeling, dhr, complaint history, and risk reviews were completed with no deficiencies, discrepancies or adverse trends noted.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 the surgeon used 2 spinal cages for anterior cervical discectomy and fusion (acdf).The surgeon informed that the cage moved forward 2 days after surgery, he should perform surgery again.No other adverse patient consequences were reported.This event occurred in japan and is reportable to pmda.

• Brand Name: MODULUS
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• 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: 24404575
• Report Number: 2031966-2026-00031
• Device Sequence Number: 8300273
• Product Code: ODP
• UDI-Device Identifier: 00887517984173
• UDI-Public: 00887517984173
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172676
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: 67940068P2
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/06/2026
• 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