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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

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COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT LXB Back to Search Results
Catalog Number 92128
Device Problem Loss of Osseointegration (2408)
Patient Problem Inadequate Osseointegration (2646)
Event Date 12/18/2015
Event Type  Injury  
Manufacturer Narrative

This report is filed february 9, 2016. Device not received by manufacturer.

 
Event Description

Per the clinic, the patient experienced a loss of osseointegration on (b)(6) 2015. It is unknown whether the loss of osseointegration resulted in a fixture loss.

 
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Brand NameFLANGE FIXTURE AND ABUTMENT
Type of DeviceLXB
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW 435 22
Manufacturer Contact
bianca hanlon
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key5418208
MDR Text Key37717476
Report Number6000034-2016-00362
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeCO
PMA/PMN NumberK955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial
Report Date 01/28/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device Catalogue Number92128
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2016
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: 02/08/2016 Patient Sequence Number: 1
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