MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS SPINAL FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	55005-095-080
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Malunion of Bone (4529)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Event or Problem Description
A patient underwent a spinal procedure on an unknown date.It was reported that about 12 months postoperatively, the s2ai screw broke at the neck.Revision surgery took place on (b)(6) 2026 to remove both parts of the broken screw.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 24393922
• Report Number: 2027467-2026-00025
• Device Sequence Number: 8289958
• Product Code: NKB
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K214006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 55005-095-080
• Device Catalogue Number: 55005-095-080
• Device Lot Number: AP01464
• Date Returned to Manufacturer: 02/17/2026
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female