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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT LXB: PRODUCT CODE

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COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT LXB: PRODUCT CODE Back to Search Results
Catalog Number 90432
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

This report is filed, june 6, 2016. The implanted device remains.

 
Event Description

It was reported that the patient may have developed an infection at the implant site. The implanted device remains.

 
Manufacturer Narrative

Per the clinic, the patient experienced an infection of the mastoid bone and subsequently underwent surgery to remove infected bone (date not reported). This report is submitted february 20, 2017.

 
Manufacturer Narrative

Correction: the previous follow up mdr submitted on february 20, 2017, was filed inadvertently. The infection was not device related. This report is filed on february 24, 2017. (b)(4).

 
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Brand NameFLANGE FIXTURE AND ABUTMENT
Type of DeviceLXB: PRODUCT CODE
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvagen 14
po box 82
moinlycke SE-43 5 22
SW SE-435 22
Manufacturer Contact
kristel kohne
1 university avenue
macqaurie university, nsw, CO 2109
AS   2109
3037909010
MDR Report Key5701922
MDR Text Key46646868
Report Number6000034-2016-01135
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
PMA/PMN NumberK955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Type of Report Initial,Followup,Followup
Report Date 12/12/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/06/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue Number90432
Device LOT Number005CMC
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/06/2016 Patient Sequence Number: 1
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