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

Model Number	BCI602 Bone Conduction Implant
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	09/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
User presented in the emergency room with the bci partially extruded.Device explantation is scheduled.

• Brand Name: Bonebridge
• Common Device Name: BCI Bone Conduction Implant
• Manufacturer (Section D): MED-EL Elektromedizinische Geraete GmbH; innsbruck ; AU
• MDR Report Key: 50914471
• Report Number: 1066702-2026-00020
• Device Sequence Number: 14795000
• Product Code: PFO
• UDI-Device Identifier: 09008737524838
• UDI-Public: (01)09008737524838
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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 Model Number: BCI602 Bone Conduction Implant
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 03/04/2025
• 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
• Patient Age: 16 YR
• Patient Sex: Female