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U.S. Department of Health and Human Services

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

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COCHLEAR BONE ANCHORED SOLUTIONS AB ATTRACT SYSTEM LXB: PRODUCT CODE Back to Search Results
Catalog Number 92129
Device Problem Missing Value Reason (3192)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative

This report is filed, february 2, 2016. The implanted device remains.

 
Event Description

Per the clinic, the patient experienced a loose internal magnet. Subsequently on (b)(6)2016, the patient underwent revision surgery to tighten the internal magnet. During the procedure, it was reported that there was a benign cyst located between the skull and internal magnet. The cyst was fluid filled and believed to be putting pressure on the internal magnet, loosening it. The cyst was drained. The implanted device remains. As of report on (b)(6) 2016, the site is healing well with no signs of the cyst returning.

 
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Brand NameATTRACT SYSTEM
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
nicole hille
13059 east peakview ave
centennial, CO 80111
3037909010
MDR Report Key5405947
MDR Text Key37333404
Report Number6000034-2016-00181
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
Type of Report Initial
Report Date 01/13/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/02/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue Number92129
Device LOT Number173532
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 Received01/13/2016
Was Device Evaluated By Manufacturer? No
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: 02/02/2016 Patient Sequence Number: 1
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