MAUDE Adverse Event Report: AURORA SPINE, INC. APOLLO; APOLLO ANTERIOR CERVICAL PLATE SYSTEM

Model Number	115-001-14
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The original surgery date was (b)(6) 2025.Subsidence and proud screw observed during post surgery exam.
Additional Manufacturer Narrative
Only one device identifier (hibcc) is known for this report: (b)(6).There is no revision surgery scheduled and patient is being monitored by physician.No definiitve conclusions have been reached to date.
Additional Manufacturer Narrative
The month the complaint was received by manufacturer was incorrectly entered as june.The correct month is july.Field g3 is corrected.

• Brand Name: APOLLO
• Common Device Name: APOLLO ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): AURORA SPINE, INC.; 1930 palomar point way; suite 103; carlsbad CA 92008
• Manufacturer (Section G): AURORA SPINE, INC.; 1930 palomar point way; suite 103; carlsbad CA 92008
• Manufacturer Contact: laszlo garamszegi ; 1930 palomar point way; suite 103; carlsbad, CA 92008
• MDR Report Key: 22827821
• Report Number: 3010326971-2025-00002
• Device Sequence Number: 14590800
• Product Code: KWQ
• UDI-Device Identifier: B521115001140
• UDI-Public: B521115001140
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K210325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: 115-001-14
• Device Lot Number: 7524-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2023
• 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: 74 YR
• Patient Sex: Female