MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH BONEBRIDGE; BCI BONE CONDUCTION IMPLANT

Model Number	BCI602 BONE CONDUCTION IMPLANT
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device investigation revealed a damage to the device likely caused by 3t magnet resonance imaging (mri).A 3t mri is contraindicated for this device type.Other mechanical damages are likely related to the explantation surgery.The recipient was reimplanted with a cochlear implant to allow further mri examinations.This is a combined initial and final report.
Event or Problem Description
User is in need of frequent mri so decision was taken to reimplant with a cochlea implant.

• 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: 23755140
• Report Number: 9710014-2025-01144
• Device Sequence Number: 5904786
• Product Code: PFO
• UDI-Device Identifier: 09008737524838
• UDI-Public: (01)09008737524838
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2025

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 Model Number: BCI602 BONE CONDUCTION IMPLANT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 78 YR
• Patient Sex: Female