MAUDE Adverse Event Report: ALPHATEC SPINE, INC. THE EPAD 2 SYSTEM; STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Model Number	AIX11901
Medical Device Problem Code	Device Provides Uninformative Message (4082)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The unit did not return for evaluation; however, a photograph of the error message was provided.The system is designed to display pop-up messages to assist users in assessing device status or troubleshooting.After the procedure was cancelled, the sales representative performed a manual reset, which resolved the issue.The error message was likely the result of the unit receiving high current.
Event or Problem Description
The system displayed an error message after patient positioning and skin marking, but prior to skin incision.Baseline recordings had already been successfully obtained prior to the alert.Troubleshooting was attempted but did not resolve the issue.The surgeon elected to cancel the procedure.
Additional Manufacturer Narrative
Correction: d1.Safeop 1.5 head unit.

• Brand Name: THE EPAD 2 SYSTEM
• 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: 23810981
• Report Number: 2027467-2025-00258
• Device Sequence Number: 18063712
• Product Code: GWF
• UDI-Device Identifier: 00190376330723
• UDI-Public: (01)00190376330723
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K182542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: AIX11901
• Device Catalogue Number: AIX11901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2021
• 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