MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH Bonebridge; BCI Bone Conduction Implant

Model Number	BCI602 Bone Conduction Implant
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026 the user's implant site was hit with significant force and in close range.Pain around the implant site was reported and is still present.
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it 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
On (b)(6) 2026, the user hit the implant site with significant force and in close range.
Additional Manufacturer Narrative
According to the information received from the field a technical implant failure due to the reported trauma seems likely.However, to determine an exact root cause device investigation of the explanted device is necessary.At this time, there is no information available regarding the next steps.

• 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()577885626
• MDR Report Key: 25443837
• Report Number: 9710014-2026-00528
• Device Sequence Number: 5815352
• Product Code: PFO
• UDI-Device Identifier: 09008737524838
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/23/2026
• 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: 06/03/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 05/23/2023
• 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: 54 YR
• Patient Sex: Female