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 Codes	Unspecified Infection (1930); Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient developed an infection (site of infection not confirmed), wound breakdown, and extrusion of the device.Subsequently, the patient was treated with an iv antibiotics during surgery, 2-week course of oral antibiotics (specific dates not reported) and topical antibiotics (specific date and duration not reported) to treat the reported issues.There are plans to explant the device; however, this has not occurred as of the date of this report.Additional information has been requested but 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
• Manufacturer (Section G): Cochlear Ltd; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: nur fitrahana mohd yusop ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50726116
• Report Number: 6000034-2026-03193
• Device Sequence Number: 21479385
• Product Code: PFO
• UDI-Device Identifier: 09321502070676
• UDI-Public: (01)09321502070676(11)260320(17)280319
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K231204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2026
• 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: Required Intervention
• Patient Sex: Female