MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS SPINAL FIXATION SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	17100-18-1
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During attempted screw placement into the l4/l5/s vertebral body, ossification was encountered.Prior to inserting the screw, a tap was advanced over the guidewire.On fluoroscopy, the guidewire tip appeared to be retained within the vertebral body.The guidewire was removed for inspection and comparison with a new guidewire confirmed that approximately 2mm of the tip had sheared off.The retained fragment was embedded within the ossified vertebral body and could not be safely removed.Based on the surgeon's clinical judgment, screw placement proceeded with the guidewire tip left in situ.Because the fragment was securely contained within the ossified vertebral body, no displacement was observed on intraoperative or postoperative imaging.
Additional Manufacturer Narrative
The device is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
Correction: h3.Yes h6.Investigation findings: 3252 investigation conclusions: 61.Device evaluation: visual inspection confirms the event.The guidewire tip is sheared at the distal end.The root cause is likely increased resistance while tapping ossified bone.If the tap was redirected while the guidewire remained inserted through the cannulation, the guidewire could bend and become trapped beneath the tap.Continued advancement of the tap over the constrained guidewire may result in shearing of the guidewire tip.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.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 23647301
• Report Number: 2027467-2025-00247
• Device Sequence Number: 17349203
• Product Code: LXH
• UDI-Device Identifier: 00190376220246
• UDI-Public: (01)00190376220246
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 17100-18-1
• Device Catalogue Number: 17100-18-1
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 05/06/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male