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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
Model Number BIA300
Device Problem Loss of Osseointegration (2408)
Patient Problem Hearing Loss (1882)
Event Type  Injury  
Manufacturer Narrative

The date of initial implantation is not unknown. Device not returned to manufacturer.

 
Event Description

Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss (date not reported). Revision surgery is planned; however, has yet to occur as of the date of this report, (b)(6) 2016.

 
Manufacturer Narrative

Per the clinic, the patient underwent revision surgery on (b)(6) 2017, in order to place an internal magnet. The implanted fixture remains insitu. This report is submitted january 19, 2017.

 
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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
2 9428 655
MDR Report Key5687693
MDR Text Key46158339
Report Number6000034-2016-01086
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeSN
PMA/PMN NumberK955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/20/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/30/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberBIA300
Device Catalogue Number92346
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 Received12/20/2016
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: 05/30/2016 Patient Sequence Number: 1
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