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

Model Number	CI-1601-05
Medical Device Problem Codes	Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Wound Infection (2447)
Date of Event	05/14/2026
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 company was informed that the recipient's device was repositioned.Prior to repositioning, the surgeon reported a visible skin breakdown, and the device exposed, however, no clear infection signs were noted.During the repositioning surgery, the surgeon cleaned the implant site and sutured the skin.The recipient is healing well.
Additional Manufacturer Narrative
Additional information: section b3, d6b, d.9 & h6.The recipient experienced recurrent skin breakdown, suspected to be secondary to infection.The device was explanted following treatment with multiple courses of antibiotics.Intraoperative findings did not reveal active purulence; however, infection is suspected.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Additional Manufacturer Narrative
Advanced bionics considers the investigation into this reportable event as closed.The recipient will be reimplanted at a later date.The recipient has healed.The external visual inspection revealed the electrode was severed.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented a electrical test from being performed.The device passed the electrical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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¿ 3D ULTRA IMPLANT
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: corrina desales ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 24933787
• Report Number: 3006556115-2026-00386
• Device Sequence Number: 18823350
• Product Code: MCM
• UDI-Device Identifier: 07630016878008
• UDI-Public: (01)07630016878008(11)220825(17)250831
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P960058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 03/30/2026

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: 08/31/2025
• Device Model Number: CI-1601-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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; Not provided
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/21/2026; 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• 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 Age: 73 YR
• Patient Sex: Female