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

Model Number	5155072
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an excavation pituitary snapped off intra-operatively.
Additional Manufacturer Narrative
The device has not returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Additional Manufacturer Narrative
The investigation revealed a reported event where the tip of the excavation pituitary, 2mm straight fractured during a tlif procedure on (b)(6) 2025.No adverse effects to the patient were reported and the procedure was able to be completed.A complaint product review was completed.The instrument was inspected and it was confirmed that the 2mm straight pituitary (p/n (b)(6)) had a fractured tip.While the exact root cause is unknown, it is possible that excessive force was applied to the instrument, resulting in the articulating tip breaking in two.Labeling, 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
It was reported that the tip of an excavation pituitary snapped off intra-operatively.

• 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: 22882728
• Report Number: 2031966-2025-00105
• Device Sequence Number: 13171864
• Product Code: LXH
• UDI-Device Identifier: 00887517974181
• UDI-Public: 00887517974181
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 04/16/2026

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: 5155072
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown