MAUDE Adverse Event Report: Cochlear Ltd Cochlear Osia OSI200 Implant; Cochlear¿ Osia¿ System

Model Number	OSI200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced hearing changes that led to no longer being a candidate for the transcutaneous osia implant system.The device was explanted on (b)(6) 2026, and the patient was reimplanted with another cochlear device during the same surgery.

• Brand Name: Cochlear Osia OSI200 Implant
• Common Device Name: Cochlear¿ Osia¿ System
• Manufacturer (Section D): Cochlear Ltd; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 50878200
• Report Number: 6000034-2026-03359
• Device Sequence Number: 10674300
• Product Code: PFO
• UDI-Device Identifier: 09321502046152
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 09/24/2026
• Report Date (Section F): 09/24/2026

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: 11/17/2022
• Device Model Number: OSI200
• Device Catalogue Number: P1170466
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/31/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 09/24/2026