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

Model Number	15100
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent a spinal surgery on an unknown date.Around 6 months postoperatively, a radiograph image revealed that a set screw had backed out.Revision surgery occurred to remove the set screw.Around 6 weeks postoperatively of the revision surgery, a radgiograph image revealed that another set screw had backed out.There are no plans for revision surgery for this second incident.This is report 2 of 2.
Additional Manufacturer Narrative
The screw has not returned for evaluation as it remains in situ.Radiographs were provided which confirm the event of a set screw backout.A review of the device history records could not be performed as the identifying lot number was not provided.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 ; 7603566777
• MDR Report Key: 22310808
• Report Number: 2027467-2025-00147
• Device Sequence Number: 8621717
• Product Code: NKB
• UDI-Device Identifier: 00190376137902
• UDI-Public: (01)00190376137902
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181677
• 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): 06/23/2025

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: 15100
• Device Catalogue Number: 15100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/23/2025
• 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
• Patient Sex: Unknown