MAUDE Adverse Event Report: Alphatec Spine, Inc. Invictus Spinal Fixation System; SCREWDRIVER

Model Number	17111
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the driver broke off during a case.The tip was retrieved.
Additional Manufacturer Narrative
Visual inspection confirms that the distal tip of driver has sheared off, along with a portion of the distal shaft.The failure is likely due to input torque exceeding the strength of the tip.Review of device history records showed no manufacturing or processing related irregularities.Labeling review: warnings/cautions/precautions: risks identified with the use of these devices, which may require additional surgery, include device component failure, loss of fixation/stabilization, non-union, vertebral fracture, neurological injury, vascular or visceral injury.Possible adverse effects: initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components.

• Brand Name: Invictus Spinal Fixation System
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): Alphatec Spine, Inc.; 1950 camino vida roble; calrsbad 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 ; +1(760)356-6777
• MDR Report Key: 50008555
• Report Number: 2027467-2026-00162
• Device Sequence Number: 5940281
• Product Code: HXX
• UDI-Device Identifier: 00190376192710
• UDI-Public: (01)00190376192710(10)TI00031
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 07/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 17111
• Device Catalogue Number: 17111
• Device Lot Number: TI00031
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/13/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• 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
• Patient Sex: Unknown