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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH BONEBRIDGE; BCI BONE CONDUCTION IMPLANT
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MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH BONEBRIDGE; BCI BONE CONDUCTION IMPLANT Back to Search Results
Model Number BCI601 BONE CONDUCTION IMPLANT
Medical Device Problem Code Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes Unspecified Infection (1930); Tissue Breakdown (2681)
Date of Event 05/22/2020
Type of Reportable Event Serious Injury
Event or Problem Description
The user reported pain at the implant site.The device was still functioning prior to being removed.The device was explanted on (b)(6) 2020.According to the explantation report there was an extrusion and wound healing issues.In addition there was a report of biofilm formation.
 
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Brand Name
BONEBRIDGE
Common Device Name
BCI BONE CONDUCTION IMPLANT
Manufacturer (Section D)
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
innsbruck
AU 
MDR Report Key10127142
Report Number1066702-2020-00037
Device Sequence Number2153155
Product Code PFO
UDI-Device Identifier09008738510328
UDI-Public(01)09008738510328
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P990052
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Importer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/08/2020
Report Date (Section F) 05/22/2020
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? No
Operator of Device Health Professional
Device Model NumberBCI601 BONE CONDUCTION IMPLANT
Device Catalogue Number51032
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/22/2020
Event Location Hospital
Date Report to Manufacturer05/22/2020
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/08/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age23 YR
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