MAUDE Adverse Event Report: Cochlear Ltd Cochlear Osia OSI200 Implant; Cochlear¿ Osia¿ System

Model Number	OSI200
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Tissue Breakdown (2681)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced pain and extrusion of the implanted device.The device was explanted on (b)(6) 2026, and during the surgical procedure, revitalization of the wound margins in the necrotic zone was performed and the dissected area sutured with monocryl.It is unknown if there are plans to reimplant the patient 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.
Additional Manufacturer Narrative
Device analysis report attached.

• Brand Name: Cochlear Osia OSI200 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: amirah rosly ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50490213
• Report Number: 6000034-2026-03002
• Device Sequence Number: 18757469
• Product Code: PFO
• UDI-Device Identifier: 09321502046152
• UDI-Public: (01)09321502046152(11)240516(17)260515
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K191921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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 Expiration Date: 05/15/2026
• Device Model Number: OSI200
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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: Unknown