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

Model Number	525-400-01
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted once the investigation has concluded.
Event or Problem Description
During an l2-s1 posterior fixation procedure, the navigation system intermittently lost recognition of tracked instruments and the patient array despite continued visualization of tracking spheres.Loss of positional tracking occurred while a pedicle screw was partially inserted, requiring screw removal and robotic realignment after tracking was restored.This resulted in a procedural delay.One screw was reported to be placed medially.Postoperatively, the patient reported leg pain.

• Brand Name: VALENCE 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 92208
• Manufacturer Contact: michael hendrickson ; 1950 camino vida roble; carlsbad, CA 92008 ; 7603566777
• MDR Report Key: 24990090
• Report Number: 2027467-2026-00015
• Device Sequence Number: 10491304
• Product Code: OLO
• UDI-Device Identifier: 00190376681177
• UDI-Public: (01)00190376681177
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K252597
• 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): 04/24/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 525-400-01
• Device Catalogue Number: 525-400-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/24/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown