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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92127
Device Problem Loss of Osseointegration (2408)
Patient Problem Unspecified Infection (1930)
Event Date 12/08/2020
Event Type  Injury  
Event Description

Per the clinic, the patient experienced a bone infection and lack of osseointegration, resulting in loss of fixture. The implant and abutment were both removed on (b)(6) 2020. It is unknown if there are plans to reimplant the patient as of the date of this report.

 
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Brand NameBIA300 IMPLANT 4MM W ABUTMENT 6MM
Type of DeviceCOCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW 435 22
MDR Report Key11052238
MDR Text Key223055044
Report Number6000034-2020-03551
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/01/2021,03/05/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2016
Device MODEL Number92127
Device Catalogue Number92127
Device LOT Number89175
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/01/2021
Distributor Facility Aware Date03/05/2021
Event Location No Information
Date Report TO Manufacturer03/05/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/21/2020 Patient Sequence Number: 1
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