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

Model Number	BCI601 Bone Conduction Implant
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user reported that in (b)(6) 2023 he lost access to sound with the device.
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.
Additional Manufacturer Narrative
According to the information received from the field a technical implant failure due to the reported impact seems likely.However to determine an exact root cause device investigation of the explanted device is necessary.Furthermore it was reported that the recipient's hearing deteriorated postoperatively and the user is no longer within indication criteria for the device.Re-implantation is planned but no date has been scheduled yet.This is a final report.
Event or Problem Description
The user reported that in (b)(6) 2023 he lost access to sound with the device.Re-implantation is considered.

• 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: 17949074
• Report Number: 9710014-2023-00928
• Device Sequence Number: 7670144
• Product Code: PFO
• UDI-Device Identifier: 09008738510328
• UDI-Public: (01)09008738510328
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2026

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: 07/09/2020
• Device Model Number: BCI601 Bone Conduction Implant
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 10/13/2023; 10/13/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 03/06/2024; 09/01/2026
• Date Device Manufactured: 07/09/2018
• 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: 58 YR
• Patient Sex: Male