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

Model Number	5155082
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the discectomy, the tip of the excavation clamp broke.The procedure continued without any problems for either the surgeon or the patient.The part was retrieved, no fracture part was dropped into patient, only into nurse hand during surgery.This event occurred in italy.
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.
Event or Problem Description
During the discectomy, the tip of the clamp broke.The procedure continued without any problems for either the surgeon or the patient.The part was retrieved, no fracture part was dropped into patient, only into nurse hand during surgery.
Additional Manufacturer Narrative
The investigation revealed that the complaint file was evaluated and it was determined that the report relates to a nuvasive excavation pituitary, 2mm up.The report indicates that the tip of the pituitary fractured and was removed from the patient during the procedure.There was no patient injury associated with this reported event.No products were returned to nuvasive for evaluation; further, no photographs of the devices were provided for review.The rep was contacted in an attempt to find more information, but a reply was not received.As a result, the complaint was unable to be confirmed with the information provided.Based on the reported information, an exact root cause is unknown, but it is possible the tip fractured due to excessive force applied by the user.Review of the associated risk determined the harms associated with the reported event were previously addressed and hazardous situations were reported.The severity and rate of occurrence documented in this reported event do not exceed the post-mitigated severity, or failure mode probability estimated in the risk management file.Following review, no new risks were identified.Labeling, manufacturing, and risk reviews 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.

• Brand Name: EXCAVATION
• 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: 23745090
• Report Number: 2031966-2025-00155
• Device Sequence Number: 8460188
• Product Code: LXH
• UDI-Device Identifier: 00887517974211
• UDI-Public: 00887517974211
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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: 5155082
• Device Lot Number: FD4699408
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/15/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 75 KG