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

Model Number	55005-105-090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The screw has not returned for evaluation.Photographs were provided which confirm the event of the screw broken at the neck.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.
Event or Problem Description
It was reported that three iliac screws broke at the neck postoperatively.The initial surgery occurred on (b)(6) 2024.Postoperatively, two of the screws broke at the neck, and revision surgery occurred on (b)(6) 2025 to remove the broken screws.During this surgery, four points of iliac fixation were added.The third screw broke at the neck postoperatively and was removed on (b)(6) 2025 and replaced with the same size.This is report 2 of 3.

• 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: 22235012
• Report Number: 2027467-2025-00132
• Device Sequence Number: 8186115
• Product Code: NKB
• UDI-Device Identifier: 00190376404752
• UDI-Public: (01)00190376404752
• 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: 2024
• Device Explanted Year: 2025
• 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): 06/17/2025

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: 55005-105-090
• Device Catalogue Number: 55005-105-090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/17/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male