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

Model Number	BCI601 BONE CONDUCTION IMPLANT
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
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 device was successfully activated earlier this year.In (b)(6) 2019, after losing the external device, the recipient was playing on the playground and hit his head.In (b)(6) 2019 the audio processor was found and after putting it on the device only worked for one day.The mother then sent the audio processor for repair.The user will get a ct scan done.Follow-up with the hospital will be made to find out the results of the ct scan.
Additional Manufacturer Narrative
Additional information: according to the information received damage to the device due to the reported external impact seems likely.However, a device investigation is necessary to determine a root cause.Re-implantation is considered but no date has been scheduled yet.
Event or Problem Description
The device was successfully activated earlier in 2019.In (b)(6) 2019, after losing the external device, the recipient was playing on the playground and hit his head.In (b)(6) 2019 the audio processor was found and after putting it on the device only worked for one day.
Additional Manufacturer Narrative
Conclusion: the investigation results confirmed that the device has failed due to an external impact.The accidental fall described in the recipient report appears to match the damage found.Other damages found during investigation are attributable to the removal surgery.This is a final report.
Event or Problem Description
The device was successfully activated earlier in 2019.In (b)(6) 2019, after losing the external device, the recipient was playing on the playground and hit his head.In (b)(6) 2019 the audio processor was found and after putting it on the device only worked for one day.The user has been re-implanted.

• 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: 9320644
• Report Number: 9710014-2019-00880
• Device Sequence Number: 11488437
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2022

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: Health Professional
• Device Model Number: BCI601 BONE CONDUCTION IMPLANT
• Device Catalogue Number: 51032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 11/07/2019; 11/07/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 03/23/2020; 10/14/2022
• 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: 10 YR
• Patient Sex: Male