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

Model Number	1181050P2
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been received for evaluation.The root cause cannot be determined at this time.A supplemental report will be submitted upon receipt of additional information.
Event or Problem Description
It was reported that the patient underwent l2/l5 lateral lumbar interbody fusion and inserted cages for each intervertebral spaces.After confirming the position of the l4/5 cage with a c-arm, the surgeon attempted to adjust its placement.However, it was difficult to grasp the cage with the inserter.The surgeon tried to remove the cage using instruments e.G.Forceps but the cage was pushed further toward the opposite side.Ultimately, the cage was dislodged from the intervertebral space and migrated to the ventral aspect of the l5/sacrum.Due to the patient's posture during the surgery, the dislodged implant could not be removed.The surgeon decided to leave the cage in-situ as there was a low risk of damaging the surrounding vessels because of no spike on the cage surface.And new spinal cage was inserted into l4/5, and the surgery was completed.The surgeon commented that the patient's l5 vertebra was irregularly shaped, which interfered with the surgical instruments and made grasping the cage difficult.The dropped cage was removed by laparoscopic surgery on (b)(6) 2025.We do not receive any other adverse patient consequences reported.
Event or Problem Description
It was reported that the patient underwent l2/l5 lateral lumbar interbody fusion and inserted cages for each intervertebral spaces.After confirming the position of the l4/5 cage with a c-arm, the surgeon attempted to adjust its placement.However, it was difficult to grasp the cage with the inserter.The surgeon tried to remove the cage using instruments e.G.Forceps but the cage was pushed further toward the opposite side.Ultimately, the cage was dislodged from the intervertebral space and migrated to the ventral aspect of the l5/sacrum.Due to the patient's posture during the surgery, the dislodged implant could not be removed.The surgeon decided to leave the cage in-situ as there was a low risk of damaging the surrounding vessels because of no spike on the cage surface.And new spinal cage was inserted into l4/5, and the surgery was completed.The surgeon commented that the patient's l5 vertebra was irregularly shaped, which interfered with the surgical instruments and made grasping the cage difficult.The dropped cage was removed by laparoscopic surgery on (b)(6) 2025.No other adverse patient consequences reported.
Additional Manufacturer Narrative
The investigation revealed a complaint reporting that the patient underwent l2/l5 lateral lumbar interbody fusion and inserted cages for each intervertebral space.After confirming the position of the l4/5 cage with a c-arm, the surgeon attempted to adjust its placement.However, it was difficult to grasp the cage with the inserter.The surgeon tried to remove the cage using instruments, but the cage was pushed further toward the opposite side.Ultimately, the cage was dislodged from the intervertebral space and migrated to the ventral aspect of the l5/sacrum.Due to the patient's posture during the surgery, the dislodged implant could not be removed.The surgeon decided to leave the cage in-situ as there was a low risk of damaging the surrounding vessels because of no spike on the cage surface.And new spinal cage was inserted into l4/5, and the surgery was completed.The surgeon commented that the patient's l5 vertebra was irregularly shaped, which interfered with the surgical instruments and made grasping the cage difficult.The dropped cage was removed by laparoscopic surgery on (b)(6) 2025.There was no other adverse patient consequence reported.No device was returned for evaluation, and limited information is available apart from the pictures provided.No additional investigation required.Review of the device history of the most recent date of event records notes no material non-conformance¿s, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Review of the associated risk determined the hazards associated with the reported event were previously addressed.Following review, no new risks were identified.Therefore, the overall risk has been maintained, and no further corrective actions are required.Labeling, manufacturing, complaint history, and risk reviews were completed with no deficiencies, discrepancies, or adverse trends identified.The event will be used for trend data.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.

• 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: 23988704
• Report Number: 2031966-2026-00003
• Device Sequence Number: 11919911
• Product Code: MAX
• UDI-Device Identifier: 00887517725882
• UDI-Public: 887517725882
• 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
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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: 1181050P2
• Device Lot Number: N435376
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 07/07/2026
• 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: Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 114 LB