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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92129
Device Problem Loss of Osseointegration (2408)
Patient Problem Unspecified Infection (1930)
Event Date 07/01/2020
Event Type  Injury  
Manufacturer Narrative

This report is submitted on april 16, 2021.

 
Event Description

Per the surgeon, the patient's skin flap became infected (treated with oral antibiotics) and the implant became loose. The patient was hospitalised and the implant was removed under a general anaesthetic.

 
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Brand NameBI300 IMPLANT 4 MM
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
Manufacturer Contact
roberta loveday
1 university avenue
macquarie university, nsw 2109,
AS   2109,
MDR Report Key11676241
MDR Text Key245735828
Report Number6000034-2021-00962
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 03/22/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92129
Device Catalogue Number92129
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/15/2021 Patient Sequence Number: 1
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