MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS OCT SPINAL FIXATION SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	19000-40-18
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In (b)(6) 2024, a patient underwent a posterior cervical fusion procedure at levels c1-c2.Around 3 months postoperatively, a radiograph image revealed a screw at c2 had broken at the neck.
Additional Manufacturer Narrative
The implant remains in situ.Radiographs were provided which confirm the event of a broken screw at the c2 level.The lot number was not provided; therefore, a review of device history records cannot be performed.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.Postoperative management: patient should be informed and compliant with the purpose and limitations of the implant devices.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 possible consequences of any type of early or excessive weight bearing, vibratory motion, fall, jolts, or other movements preventing proper healing and/or fusion development.In the case of delayed, mal-, or non-union of bone, the patient must continue to be immobilized in order to prevent bending, dislocation, or breakage of the implant devices.Immobilization should continue until a complete bone fusion mass has developed and been confirmed.

• Brand Name: INVICTUS OCT SPINAL FIXATION SYSTEM
• Common Device Name: POSTERIOR CERVICAL 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: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 21435983
• Report Number: 2027467-2025-00014
• Device Sequence Number: 19965009
• Product Code: NKG
• UDI-Device Identifier: 00190376302911
• UDI-Public: (01)00190376302911
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203125
• 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): 02/21/2025

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: 19000-40-18
• Device Catalogue Number: 19000-40-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/21/2025
• 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