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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 Problems Discharge (2225); Impaired Healing (2378)
Event Date 10/11/2017
Event Type  Injury  
Manufacturer Narrative

The reported adverse event is associated with a product that was not returned, or was not made available for analysis. The manufacturer investigation was based on the available clinical information. The reported issue is a known medical complication and no specific device analysis is deemed necessary at this time. This report is submitted on november 8, 2017, by cochlear ltd. On behalf of cochlear americas. (b)(4).

 
Event Description

Per the clinic, the patient experienced a wound healing impairment with intermittent discharge, following removal of the abutment due to non-use. Subsequently, the implant fixture was explanted on (b)(6) 2017. There are currently no plans to reimplant the patient with another device, as of the date of this report.

 
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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
Manufacturer (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke 43533
SW 43533
Manufacturer Contact
bianca pries
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key7008038
MDR Text Key91287921
Report Number6000034-2017-01981
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
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 10/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/07/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/01/2014
Device MODEL Number90434
Device Catalogue Number90434
Device LOT Number011CMC
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/19/2017
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: 11/07/2017 Patient Sequence Number: 1
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