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U.S. Department of Health and Human Services

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

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COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA ATTRACT SYSTEM LXB Back to Search Results
Model Number N/A
Device Problem Extrusion (2934)
Patient Problem Tissue Breakdown (2681)
Event Date 02/05/2016
Event Type  Injury  
Manufacturer Narrative

This report is filed march 30, 2016. The implanted device remains.

 
Event Description

Per the clinic, the patient experienced skin flap breakdown (b)(6) 2016 resulting in extrusion of the internal magnet. Subsequently the patient underwent a rotational skin flap revision (date not reported). On (b)(6) 2016, the patient experienced skin flap breakdown and extrusion of the internal magnet for a second time. On (b)(6) 2016, the internal magnet was removed and a cover screw was placed on the implant. The implanted device remains.

 
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Brand NameBAHA ATTRACT SYSTEM
Type of DeviceLXB
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, se 435-2 2
SW 435-22
Manufacturer Contact
angel wright
13059 east peakview avenue
centennial, CO 80111
3037909010
MDR Report Key5536434
MDR Text Key41491577
Report Number6000034-2016-00626
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 COMPANY REPRESENTATIVE
Reporter Occupation AUDIOLOGIST
Type of Report Initial
Report Date 03/07/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/30/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue Number93550
Device LOT Number103650
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 Received03/07/2016
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: 03/30/2016 Patient Sequence Number: 1
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