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

Model Number	19000-55-30
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent a posterior cervical fusion procedure at c2-t3.It was reported that while inserting the polyaxial screw at c2, it broke at the transition portion of the shank between the treads and tulip head.The broken screw shank was removed from the patient.This caused greater than 30 minutes of a delay in surgery.This is report 1 of 2.
Additional Manufacturer Narrative
The implant is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
A1.(b)(6).D4.Model #: 19000-45-32; catalog #: 19000-45-32; lot #: sm172559; primary udi #: (b)(4).H4.11/08/2023.
Additional Manufacturer Narrative
This is report 1 of 2.Corrected information: h3.Yes h6.Investigation findings: 3252 investigation conclusion: 4310, 19 device evaluation: visual inspection of the tulip confirms the screw sheared at the shank neck.The threaded screw shank did not return.The patient's medical history or bone characteristics is unknown.Based on the information provided, it is likely the torsional force used to insert the screw exceeded the torsional yield strength of the shank neck causing it to fracture.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
• 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: 20535977
• Report Number: 2027467-2024-00131
• Device Sequence Number: 15508617
• Product Code: NKG
• UDI-Device Identifier: 00190376303697
• UDI-Public: (01)00190376303697(10)TO02788
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2024

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: 19000-55-30
• Device Catalogue Number: 19000-55-30
• Device Lot Number: TO02788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 10/28/2024; 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2023
• 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 Age: 68 YR
• Patient Sex: Male