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

Model Number	15295-55-120-S
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Event or Problem Description
During insertion of the pre-bent rod, it was noticed that the rod had an excessive bend.The surgeon attempted to straighten the rod using a rod bender, at which point the snake-eye portion at the distal tip fractured.All broken fragments were retrieved without incident.The procedure was completed successfully using a new rod, and no patient harm was reported.
Additional Manufacturer Narrative
Correction: h3.Yes h6.Investigation findings: 3252 investigation conclusions: 61 device evaluation: visual inspection confirms the event.The blunt nose tip has broken completely off.It appears that the rod has been straightened near the bullet.The root cause is excessive bending loads.If a user attempts to bend a rod too close to the blunt nose or with one of the bending contact points on the blunt nose itself, the smaller cross section of the connection will buckle and cause the tip to fracture off.Review of device history records showed no manufacturing or processing related irregularities that would cause or contribute to this failure mode.Labeling review: warnings/cautions/precautions: risk factors that may affect successful surgical outcomes include alcohol abuse, obesity, patients with poor bone, muscle and/or nerve quality.Patients who use tobacco or nicotine products should be advised of the consequences that an increased incidence of non-union has been reported with patients who use tobacco or nicotine products.Possible adverse effects: initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components.

• 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: 23650368
• Report Number: 2027467-2025-00246
• Device Sequence Number: 4769703
• Product Code: NKB
• UDI-Device Identifier: 00190376269771
• UDI-Public: (01)00190376269771(10)10354110
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: 15295-55-120-S
• Device Catalogue Number: 15295-55-120-S
• Device Lot Number: 10354110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2024
• 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: Male