MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES¿ ULTRA 3D IMPLANT; COCHLEAR IMPLANT

Model Number	CI-1601-04
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Expulsion (2933)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Event or Problem Description
The recipient reportedly experienced electrode extrusion.Revision surgery is under consideration.
Additional Manufacturer Narrative
Additional information: section d.6b, h.6 advanced bionics considers the investigation into this reportable event as closed.Per surgeon, the recipient will need to first have a free tissue transfer before considering a revision surgery.Due to the stable appearance of the exposed device and no signs of infections it is suggested to continue monitoring.The recipient will be monitored by the facilities protocols.No further treatment information will be provided.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES¿ ULTRA 3D IMPLANT
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: rita nicholson ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 23384118
• Report Number: 3006556115-2025-01426
• Device Sequence Number: 18340595
• Product Code: MCM
• UDI-Device Identifier: 07630016877995
• UDI-Public: (01)07630016877995(11)211020(17)240930
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P960058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2024
• Device Model Number: CI-1601-04
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female