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

Model Number	19003-35-32
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A female patient underwent a posterior cervical fusion procedure.Around 6 months postoperatively, a radiograph image revealed a broken screw at c1.The patient is asymptomatic.There are no plans for revision surgery.The surgeon will continue to monitor the patient.
Additional Manufacturer Narrative
The implant remains in-situ.No evaluation possible.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.Based on the information provided, the root cause could not be determined.The implant was used for treatment, not diagnosis.Possible adverse effects: the following complications and adverse reactions have been shown to occur with the use of similar spinal instrumentation.These effects and any other known by the surgeon must be discussed with the patient preoperatively.1.Initial or delayed loosening, disassembly, bending, dislocation and/or breakage of device components.
Additional Manufacturer Narrative
Additional information: d6a.05/10/2023.

• 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: wes channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 18373140
• Report Number: 2027467-2023-00091
• Device Sequence Number: 18070148
• Product Code: NKG
• UDI-Device Identifier: 00190376303871
• UDI-Public: (01)00190376303871
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 12/21/2023

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: 19003-35-32
• Device Catalogue Number: 19003-35-32
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2023
• Supplement Date Received by Manufacturer: 12/03/2023
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 88 YR
• Patient Sex: Female