MAUDE Adverse Event Report: MED-EL Elektromedizinische Geraete GmbH Bonebridge; BCI Bone Conduction Implant

Model Number	BCI602 Bone Conduction Implant
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mastoiditis (4835)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user had a mastoid infection.The user was explanted.
Additional Manufacturer Narrative
The device has been explanted and should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

• Brand Name: Bonebridge
• Common Device Name: BCI Bone Conduction Implant
• Manufacturer (Section D): MED-EL Elektromedizinische Geraete GmbH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; +43-(577)88
• MDR Report Key: 50035387
• Report Number: 9710014-2026-00697
• Device Sequence Number: 13217846
• Product Code: PFO
• UDI-Device Identifier: 09008737524838
• UDI-Public: (01)09008737524838
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K191457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: 06/21/2025
• Device Model Number: BCI602 Bone Conduction Implant
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 06/21/2022
• 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 Age: 38 YR
• Patient Sex: Female