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

Model Number	1181850P2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Kidney or Urinary Problem (4503)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on the morning on (b)(6) 2025, the surgeon inserted the spinal cage into the l4/l5 intervertebral space using the crestline technique and performed posterior fixation of the l4/l5 vertebrae.At around 6 p.M.That day, the surgeon noticed something abnormal with the drain.And he confirmed ureteral damage, using indigo carmine.At around 8pm on the same day, the patient was transferred to another hospital with a urology department accompanied by the surgeon.The surgery was carried out.We have not received any comments from the surgeon that there were any problems with the spinal cage, other implants and used medical instruments.We did not obtain any implants and instruments.
Additional Manufacturer Narrative
The device is unavailable for evaluation as it remains in situ.The root cause cannot be determined at this time.If any additional information becomes available, a supplemental report will be submitted.

• Brand Name: MODULUS
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 24038924
• Report Number: 2031966-2026-00010
• Device Sequence Number: 21401793
• Product Code: MAX
• UDI-Device Identifier: 00887517726049
• UDI-Public: 887517726049
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163230
• 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): 01/12/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1181850P2
• 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: 12/26/2025
• Initial Report FDA Received Date: 01/12/2026
• 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: Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female