MAUDE Adverse Event Report: Alphatec Spine, Inc. Invictus Spinal Fixation System; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	55405-090-080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Spinal deformity (4886)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury

• 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 ; +1(760)356-6777
• MDR Report Key: 50936608
• Report Number: 2027467-2026-00203
• Device Sequence Number: 10722341
• Product Code: NKB
• UDI-Device Identifier: 00190376452296
• UDI-Public: (01)00190376452296
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K214006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 09/29/2026

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: 55405-090-080
• Device Catalogue Number: 55405-090-080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 64 YR
• Patient Sex: Female