MAUDE Adverse Event Report: ALPHATEC SPINE, INC. SAFEOP 3 PATIENT INTERFACE; STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Model Number	AIX11240
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The system returned for evaluation, and the tablet was unresponsive.After performing a full reboot, the free-run emg functionality was normal.A review of the system logs from an earlier procedure revealed no indication of a proper shutdown.Instead, the system entered sleep mode, as shown by multiple entries.This suggests that the power button may not have been held down long enough to initiate a full reboot prior to the procedure.The root cause is unknown but may be the result of a user interface anomaly.
Event or Problem Description
At the start of a spinal procedure, the neuromonitoring system failed to display any free-run emg activity.Multiple attempts to restart both the patient interface and the tablet were unsuccessful, resulting in the procedure being aborted.

• Brand Name: SAFEOP 3 PATIENT INTERFACE
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• 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: michael hendrickson ; 1950 camino vida roble; carlsbad, CA 92008 ; 7603566777
• MDR Report Key: 22471935
• Report Number: 2027467-2025-00128
• Device Sequence Number: 17211538
• Product Code: GWF
• UDI-Device Identifier: 00190376517506
• UDI-Public: (01)00190376517506
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K234092
• 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): 07/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: AIX11240
• Device Catalogue Number: AIX11240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• 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