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

Model Number	17402
Medical Device Problem Codes	Separation Failure (2547); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Vertebral Fracture (4520)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
While attempting to deploy the tulip onto the screw shank, the gold button reportedly did not release the tulip.During an attempt to seat the tulip head onto the screw shank, the l5 pedicle fractured.The patient is asymptomatic.
Additional Manufacturer Narrative
The inserter has not returned for evaluation.Photographs were not provided.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.

• 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: 50869884
• Report Number: 2027467-2026-00196
• Device Sequence Number: 9314135
• Product Code: NKB
• UDI-Device Identifier: 00190376270210
• UDI-Public: (01)00190376270210(10)EM51473
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 17402
• Device Catalogue Number: 17402
• Device Lot Number: EM51473
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2023
• 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: Other
• Patient Age: 75 YR
• Patient Sex: Female