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

Model Number	BCI601 BONE CONDUCTION IMPLANT
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Tissue Breakdown (2681)
Date of Event	05/22/2020
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 clinic requested an explant kit because the device was removed.The nurse who requested the kit did not have any further information on the reason for removal.Additional information received stated that the user reported pain at the implant site and that was the reason for the explantation.
Additional Manufacturer Narrative
Conclusion: 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 pain at the implant side.The surgeon further reported that the user had a history of chronic otitis media and an external auditory canal (eac) closure.The user then developed a fistula between the eac closure and the device.The device was fully functional, but the user had some chronic pain issues, thus requested removal.Damages found during device investigation are most likely related to the explantation surgery.This is a final report.
Event or Problem Description
The clinic requested an explant kit because the device was removed.At the time the complaint was made the nurse who requested the kit did not have any further information on the reason for removal.Additional information received stated that the user reported pain at the implant site and that was the reason for the explantation.It was confirmed that the surgical wound did heal completely after implantation.There was no infection present and the skin above the implant was intact.

• Brand Name: BONEBRIDGE
• Common Device Name: BCI BONE CONDUCTION IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 10118554
• Report Number: 9710014-2020-00286
• Device Sequence Number: 16682455
• Product Code: MPV
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: BCI601 BONE CONDUCTION IMPLANT
• Device Catalogue Number: 51032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR