MAUDE Adverse Event Report: NUVASIVE, INC. XLIF; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	6910220
Medical Device Problem Codes	Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was unavailable for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that while using a xlif cobb the instrument slipped and nicked an artery causing bleeding that there was intervention to address.This event occurred in japan.
Event or Problem Description
It was reported that while using a xlif cobb the instrument slipped and nicked an artery causing bleeding that there was intervention to address.The surgeon arrested bleeding by packing and hemostatic agent.On (b)(6) 2025 the surgeon confirmed with a ct scan that there were no hematoma or other abnormalities.No other adverse patient consequences reported.
Additional Manufacturer Narrative
The investigation revealed a complaint reporting while using a xlif cobb the instrument slipped and nicked an artery causing bleeding that there was intervention to address.No device was returned for evaluation and no pictures provided so the complaint could not be confirmed.This event occurred in japan.The cobb slipped to anterior side when the surgeon had been using it to remove organ of the intervertebral.It was reported that there was bleeding from the artery.The surgeon arrested bleeding by packing and hemostatic agent.On (b)(6) 2025, the surgeon confirmed with a ct scan that there were no hematoma or other abnormalities.No other patient consequences were reported.A lot number for the part was not provided.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.None of these complaints reported patient harm.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 device was dispositioned for scrap, and 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: XLIF
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 23116236
• Report Number: 2031966-2025-00125
• Device Sequence Number: 9298375
• Product Code: LXH
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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: 6910220
• 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: 09/12/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male