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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 90434
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on january 29, 2021.

 
Event Description

Per the clinic, the device was explanted on (b)(6) 2021 (reason unknown).

 
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Brand NameFLANGE FIXTURE ST 4MM W. BAHA ABUTMENT
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 Key11248823
MDR Text Key229291142
Report Number6000034-2021-00129
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/28/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number90434
Device Catalogue Number90434
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 Received01/05/2020
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/28/2021 Patient Sequence Number: 1
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