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

Model Number	BCI601 BONE CONDUCTION IMPLANT
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Output Problem (3005)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it is to 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 audiologist reported that the initial activation went fine but 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.The audiologist feels the implant may not been fixed well.The surgeon has ordered a ct scan and the audiologist is awaiting his feedback.
Additional Manufacturer Narrative
Additional information: according to the information from the field the most likely reason for the reported problem with the device are related to the used screws, which were not part of the implant kit.During the implantation the surgeon used his own screws to fixate the device which is not according to the ifu.Despite multiple requests no further information was received.
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.No further information has been made available.
Additional Manufacturer Narrative
Conclusion: device investigations did not reveal any device malfunction which can explain the reported recipient performance problem.This finding was expected as the reported problem of insufficient auditory perception appears to be related to an insufficient mechanical device coupling to the bone.The screws used in the implantation surgery were not part of the implant kit and are not in agreement with the specifications stated in the bci 601 us ifu as the screw head is too big and the shape not suitable.This is in agreement with the perceived protrusion and rattling sounds.This is a final report.
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 08-jan-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.A 2mm and a 3mm lift were used during implantation.The user was explanted on the (b)(6) 2021.Reportedly, the stylet locking screws used at implantation surgery were not the best option.

• Brand Name: BONEBRIDGE
• Common Device Name: BCI BONE CONDUCTION IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 9676170
• Report Number: 9710014-2020-00087
• Device Sequence Number: 10957178
• Product Code: PFO
• UDI-Device Identifier: 09008738521805
• UDI-Public: (01)09008738521805
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 01/21/2020; 01/21/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 08/20/2020; 05/20/2021
• 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