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

Model Number	115-002-32
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the device identifier (hibcc) is known: (b)(4) for this report.Enginering investigation is ongoing.No definitive conclusions have been reached to date.
Event or Problem Description
Revision surgery was required after apollo locking plates were broken.The original surgery date was (b)(6) 2024.A revision surgery was completed on (b)(6) 2025.

• Brand Name: APOLLO
• Common Device Name: APOLLO ANTERIOR CERVICAL PLATE
• 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: 22561199
• Report Number: 3010326971-2025-00001
• Device Sequence Number: 11738442
• Product Code: KWQ
• UDI-Device Identifier: B521115002320
• UDI-Public: B521115002320
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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: 115-002-32
• Device Catalogue Number: 115-002-32
• Device Lot Number: 7524-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male