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

Model Number	OSI200
Medical Device Problem Codes	Failure to Read Input Signal (1581); Intermittent Shock/Stimulation (2287)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Event or Problem Description
Per the clinic, the patient experienced intermittent sound with the external device and during troubleshooting, the aud could not establish connection with implanted device.Hardware exchange was attempted, but the issue persisted.The device remains implanted.There are plans to explant the device and to reimplant the patient with a new device; however, this has not occurred as of the date of this report.

• 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
• Manufacturer (Section G): Cochlear Ltd; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: hema dewi ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50536365
• Report Number: 6000034-2026-03047
• Device Sequence Number: 14965213
• Product Code: PFO
• UDI-Device Identifier: 09321502046152
• UDI-Public: (01)09321502046152(11)200110(17)220109
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: Lay User/Patient
• Device Expiration Date: 01/09/2022
• Device Model Number: OSI200
• Device Catalogue Number: P1170466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2010
• 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: Other
• Patient Sex: Male