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

Model Number	AIX11240
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a spinal procedure on (b)(6) 2025 in which intraoperative neuromonitoring was utilized.During the procedure to4 testing was passing with 4/4, and temg screw testing results showed > 20ma.Postoperative ct scans revealed a medial pedicle wall breach of the s1 screw.The patient had revision surgery on (b)(6) 2025 in which the screw was removed.
Additional Manufacturer Narrative
The system is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.

• 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: 24193393
• Report Number: 2027467-2026-00006
• Device Sequence Number: 13161863
• Product Code: GWF
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K234092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: AIX11240
• Device Catalogue Number: AIX11240
• Date Returned to Manufacturer: 01/12/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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: Required Intervention
• Patient Sex: Unknown