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	Post Operative Wound Infection (2446)
Date of Event	11/27/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The user developed an infected wound after the implantation procedure.The user was explanted.
Event or Problem Description
The user developed an infected wound after the implantation procedure.The user was explanted.
Additional Manufacturer Narrative
Device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.This finding was expected, because according to the recipient report the device was explanted due to postoperative side effects, namely the user developed an infected wound after the implantation procedure.The infection reached the level of the implant and during cleaning surgery it was observed that the implant screws loosend.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process.No available information points to the implant being the source of infection.This is a final report.Note: c1902 is chosen valid imdrf investigation findings code, but cannot be entered in required field due to fda system restrictions.

• 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 ; 57788
• MDR Report Key: 24276034
• Report Number: 9710014-2026-00122
• Device Sequence Number: 13212274
• Product Code: PFO
• UDI-Device Identifier: 09008737524838
• UDI-Public: (01)09008737524838
• Combination Product (Y/N): N
• PMA/510(K) Number: K191457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 05/13/2026

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?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male