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

Model Number	OSI300
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced skin breakdown at the edge of the coil, followed by device extrusion (specific date not reported).The patient was initially treated with oral antibiotics (specific date not reported) for 2 weeks but the issue could not be resolved.Subsequently, the device was explanted (specific date not reported).It is unknown if there are plans to reimplant the patient as of the date of this report.Additional information has been requested but it has not been made available as of the date of this report.

• 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: 50766822
• Report Number: 6000034-2026-03343
• Device Sequence Number: 9195636
• Product Code: PFO
• UDI-Device Identifier: 09321502070676
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 09/15/2026
• Report Date (Section F): 09/15/2026

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: 08/20/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2026
• 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: 09/15/2026