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

Model Number	BCI601 BONE CONDUCTION IMPLANT
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
The audiologist reported that some part of the implant is sticking out and poking up the skin.The user also reports a sound like 'pebbles in a tin can' rattling which the audiologist still has not been able to resolve, this noise was first reported on (b)(6) 2020.It was further reported that during implantation the surgeon used his own screws to fixate the device.He used 8mm stryker self-drilling / self-locking screws.This was partially due to the hospital not accepting or sterilizing any of our reusable instrumentation, which was unknown until after the case started.The user was explanted on (b)(6) 2021.This report refers to 9710014-2020-00087.For further information please refer to this report.

• Brand Name: BONEBRIDGE
• Common Device Name: BCI BONE CONDUCTION IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 11587124
• Report Number: 1066702-2021-00025
• Device Sequence Number: 2956091
• Product Code: PFO
• UDI-Device Identifier: 09008738521805
• UDI-Public: (01)09008738521805(11)190701(17)210701
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2021
• Report Date (Section F): 03/15/2021

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: BCI601 BONE CONDUCTION IMPLANT
• Device Catalogue Number: 52180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/15/2021
• Event Location: Other
• Date Report to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2021
• 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: 64 YR