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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA ATTRACT SYSTEM LXB

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COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA ATTRACT SYSTEM LXB Back to Search Results
Model Number BIM400
Device Problem Extrusion (2934)
Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative

The date of initial implantation is unknown at the time of this report. This report is submitted on september 23, 2016, by cochlear limited on behalf of cochlear americas. (b)(4). Magnet not received by manufacturer.

 
Event Description

Per the clinic, the patient experienced extrusion of the internal magnet. Subsequently, revision surgery was performed on (b)(6) 2016, to remove the magnet. During the procedure, an abutment was placed on the fixture. The implanted device remains.

 
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Brand NameCOCHLEAR BAHA ATTRACT SYSTEM
Type of DeviceLXB
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW 435 22
Manufacturer (Section G)
COCHLEAR AMERICAS
13059 east parkview avenue
centennial CO 80111
Manufacturer Contact
bianca hanlon
1 university avenue
macqaurie university, nsw 2109
AS   2109
2 9428 655
MDR Report Key5972187
MDR Text Key55420840
Report Number6000034-2016-01855
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK131240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation AUDIOLOGIST
Type of Report Initial
Report Date 09/02/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/22/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberBIM400
Device Catalogue Number94336
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date09/02/2016
Event Location No Information
Date Manufacturer Received09/02/2016
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: 09/22/2016 Patient Sequence Number: 1
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