MAUDE Adverse Event Report: NUVASIVE, INC. XLIF; EXTERNAL SPINAL FIXATION SYSTEM

Model Number	6940430
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
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 the tip of a xlif pituitary broke off during surgery and had to be retrieved.
Additional Manufacturer Narrative
The investigation revealed a complaint reporting that the tip of a xlif pituitary broke off during surgery and had to be retrieved.No device was returned for evaluation and no radiographs provided so the complaint could not be confirmed.This event occurred intra-operatively.The patient experienced no adverse consequence as a result of the failure and all pieces were removed.No additional investigation required.Review of the device history 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.The worst case estimated severity and rate of occurrence documented that no new risks were identified.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.
Event or Problem Description
The pituitary mouth broke off while trying to do discectomy.All parts were retrieved.

• Brand Name: XLIF
• Common Device Name: EXTERNAL SPINAL FIXATION SYSTEM
• 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: 22882803
• Report Number: 2031966-2025-00101
• Device Sequence Number: 9640643
• Product Code: LXH
• UDI-Device Identifier: 00887517452771
• UDI-Public: 887517452771
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 04/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6940430
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 04/22/2026
• 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
• Patient Sex: Unknown