MAUDE Adverse Event Report: ALPHATEC SPINE, INC. FUSION ROBOTIC NAVIGATION SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	525-423
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Dural Tear (1417)
Date of Event	01/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the system nor the explanted screws returned to alphatec spine for evaluation.Radiographic images were not provided.The root cause is could not be determined.
Event or Problem Description
During a spinal procedure utilizing the robotic navigation system, the surgeon initially used a non-navigated high-speed bur, tap, and screwdriver to place the first two screws.However, when attempting to place the third screw, the surgeon encountered difficulty advancing the tap due to sclerotic bone after creating a pilot hole with the non-navigated high-speed bur.As a result, the surgeon switched to a low speed navigated drill to cannulate the pedicle and placed the screw.For screws four through six, the surgeon continued using the low speed navigated drill, followed immediately by screw placement.During bony decompression, the surgeon observed a medial breach of screws #3 and #4, with one of the breaches causing a dural tear.The surgeon successfully repaired the tear and replaced the affected screws without any further complications.

• Brand Name: FUSION ROBOTIC NAVIGATION SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 21508600
• Report Number: 2027467-2025-00027
• Device Sequence Number: 4590907
• Product Code: OLO
• UDI-Device Identifier: 00190376610566
• UDI-Public: (01)00190376610566
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K232413
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

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: 525-423
• Device Catalogue Number: 525-423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 03/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown