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	Wound Dehiscence (1154); Head Injury (1879); Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a wound dehiscence, exposing the receiver/stimulator subseqent of sustaining head trauma.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 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: rosdeelaila zulkifli ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; wilayah persekutuan, kuala lumpur 59200 ; MY 59200
• MDR Report Key: 50910946
• Report Number: 6000034-2026-03468
• Device Sequence Number: 5330791
• Product Code: PFO
• UDI-Device Identifier: 09321502070676
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/25/2026

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
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2026
• 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