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

Model Number	AIX11240
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Malposition of Device (2616)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of case files for the surgery indicate the unit operated as intended.The root cause could not be determined.Alphatec spine is submitting this report to comply with the fda regulations 21 cfr 803.Alphatec spine has made reasonable efforts to provide as much relevant information as available.Any field that is left blank was not known at the time of this submission.If additional information is provided, a supplemental report will be submitted.
Event or Problem Description
A patient underwent a spinal procedure at the l4-l5 level, during which intraoperative neuromonitoring was utilized.Postoperatively, the patient developed new-onset left leg pain.Radiographic imaging revealed a medial breach of the left l5 pedicle screw.Four months after the initial surgery, revision surgery was performed to remove and replace the hardware.

• Brand Name: SAFEOP 3
• 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: 22522090
• Report Number: 2027467-2025-00137
• Device Sequence Number: 21139952
• Product Code: GWF
• UDI-Device Identifier: 00190376517506
• UDI-Public: (01)00190376517506
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K234092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 07/16/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/16/2025
• 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: Female