MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS SPINAL FIXATION SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	17140
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device did not return for evaluation.A photograph was provided which confirms the event of the tip breaking off.Review of device history records showed no manufacturing or processing related irregularities.Based on the information provided, 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.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.
Event or Problem Description
It was reported that the tip of the driver broke off when inserting a 8.5mm screw into sclerotic bone.The tip was retrieved.
Additional Manufacturer Narrative
Correction: d9.Yes, returned to manufacturer: 12/15/2025.H3.Yes.H6.Type of investigation: 10, 3331.Investigation conclusions: 61.Device evaluation: visual inspection confirms the event.Visual inspection confirms the distal t25 hexalobe has sheared off of the driver.No damage to the distal threads or sleeve is observed.The failure of the hexalobe tip is consistent with excessive/eccentric loading on the tip of the driver, likely seen from inserting or removing a screw.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 23535075
• Report Number: 2027467-2025-00238
• Device Sequence Number: 18660602
• Product Code: OLO
• UDI-Device Identifier: 00190376195902
• UDI-Public: (01)00190376195902(10)EM49324
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K153603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: 17140
• Device Catalogue Number: 17140
• Device Lot Number: EM49324
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2022
• 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 Age: 68 YR
• Patient Sex: Female