MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS SPINAL FIXATION SYSTEM; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	55203-065-045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explant is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Event or Problem Description
Approximately two months postoperatively, radiographic imaging revealed that the l5 screw shank had fractured.Revision surgery was performed to remove the screw; however, a portion of the shank remains within the vertebral body.
Additional Manufacturer Narrative
Correction: h3.Yes.H6.Investigation findings: 3252.Investigation conclusions: 61.Device evaluation: visual inspection confirms the event.The bottom portion of the screw shank has fractured off and was not returned.The fracture occurred roughly 11.5mm down the cortical threads.The tulip is undamaged, and the helical flange threads are still conforming.The root cause is likely a result of the screw not being fully seated onto the pedicle and/or fatigue as a result of high torque combined with bending loads, usually as result of attempts to redirect while driving the screw.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.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: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• 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: 23621879
• Report Number: 2027467-2025-00249
• Device Sequence Number: 21095393
• Product Code: PML
• UDI-Device Identifier: 00190376429755
• UDI-Public: (01)00190376429755(10)SM194145
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K221926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 55203-065-045
• Device Catalogue Number: 55203-065-045
• Device Lot Number: SM194145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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: Male