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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 9MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 9MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92346
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 08/14/2020
Event Type  Injury  
Manufacturer Narrative

This report is submitted on september 3, 2020.

 
Event Description

Per the clinic, the patient experienced a loosening of the abutment. The abutment was removed and replaced with an osia device on (b)(6) 2020.

 
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Brand NameBIA300 IMPLANT 4MM W ABUTMENT 9MM
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 Key10486367
MDR Text Key205458745
Report Number6000034-2020-02373
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/03/2020,08/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92346
Device Catalogue Number92346
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/03/2020
Event Location No Information
Date Report TO Manufacturer08/14/2020
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: 09/02/2020 Patient Sequence Number: 1
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