MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS SPINAL FIXATION SYSTEM; SCREWDRIVER

Model Number	17950-225
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection of the returned instrument confirmed the reported event.The distal tip is separated from the instrument.The fracture surface appears consistent with torsional overload.No additional damage or anomalies were observed on the remaining portion of the instrument.Alphatec spine, inc.Is submitting this report in compliance with fda regulations under 21 cfr 803.All relevant and available information was included to the best of our knowledge at the time of this submission.Any fields left blank reflect information that was not known or not provided.
Event or Problem Description
The tip of the screwdriver sheared off.The broken fragment was retrieved without incident.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Common Device Name: SCREWDRIVER
• 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: 25659264
• Report Number: 2027467-2026-00130
• Device Sequence Number: 17568040
• Product Code: HXX
• UDI-Device Identifier: 00190376473017
• UDI-Public: (01)00190376473017(10)EM49771
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 06/29/2026

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: 17950-225
• Device Catalogue Number: 17950-225
• Device Lot Number: EM49771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown