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

Model Number	OSI300
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient developed infection at the incision site, and subsequently, was treated with iv antibiotics for 6 weeks (date not reported).

• 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: 50718484
• Report Number: 6000034-2026-03174
• Device Sequence Number: 21492871
• Product Code: PFO
• UDI-Device Identifier: 09321502070676
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/12/2026
• Date Report to Manufacturer: 08/12/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2026
• 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: Unknown
• Date Report Sent to FDA: 09/11/2026