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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the set screw had backed out about 6 weeks postoperatively.The patient is asymptomatic, and there are no plans for revision surgery.
Additional Manufacturer Narrative
The screw has not returned for evaluation.Photographs were provided which confirm the event of a set screw backout at the t8 level.A review of the device history records could not be performed as the identifying lot number was not provided.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.Labeling review: warnings/cautions/precautions: risks identified with the use of these devices, which may require additional surgery, include device component failure, loss of fixation/stabilization, non-union, vertebral fracture, neurological injury, vascular or visceral injury.Possible adverse effects: initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components.Intraoperative management: final tightening of set screws: all set screws must be tightened using the appropriate instruments (e.G., torque handle, final driver, and counter torque) as indicated in the surgical technique guide.Postoperative management: the surgeon should instruct the patient regarding amount and time frame after surgery of any weight bearing activity.The increased risk of bending, dislocation, and/or breakage of the implant devices, as well as an undesired surgical result are consequences of any type of early or excessive weight bearing, vibratory motion, fall, jolts or other movements preventing proper healing and/or fusion development.Implant devices should be revised or removed if bent, dislocated, or broken.Immobilization should be considered in order to prevent bending, dislocation, or breakage of the implant device in the case of delayed, mal-union, or non-union of bone.Immobilization should continue until a complete bone fusion mass has developed and been confirmed.

• 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: 24766567
• Report Number: 2027467-2026-00057
• Device Sequence Number: 10267908
• Product Code: NKB
• UDI-Device Identifier: 00190376137902
• UDI-Public: (01)00190376137902
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 04/02/2026

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: 03/04/2026
• Initial Report FDA Received Date: 04/02/2026
• 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
• Patient Sex: Unknown