MAUDE Adverse Event Report: Cochlear Ltd Cochlear Osia OSI300 Implant; Cochlear¿ Osia¿ System

Model Number	OSI300
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced no sound and only received static noise with the device use.The patient reported that the device moved under the skin, however, the device was actually firmly connected to the internal fixture and had not migrated.It was also reported that the patient requires multiple mris procedures.Subsequently, the device was explanted on (b)(6) 2026, and an abutment was placed on the internal fixture.

• Brand Name: Cochlear Osia OSI300 Implant
• Common Device Name: Cochlear¿ Osia¿ System
• Manufacturer (Section D): Cochlear Ltd; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 50727330
• Report Number: 6000034-2026-03115
• Device Sequence Number: 16111991
• Product Code: PFO
• UDI-Device Identifier: 09321502070676
• UDI-Public: (01)09321502070676(11)250401(17)270331
• 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: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 09/11/2026
• Report Date (Section F): 09/11/2026

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 Model Number: OSI300
• Device Catalogue Number: P1772248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/18/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2026
• 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: 09/11/2026