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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET COCHLEAR BAHA ATTRACT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Model Number 93550
Device Problem Extrusion (2934)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 02/02/2018
Event Type  Injury  
Manufacturer Narrative

This report is submitted on on february 22, 2017. (b)(4).

 
Event Description

Per the surgeon, the patient experienced extrusion of the internal magnet. Revision surgery to repair the extrusion was completed on (b)(6) 2018. During the procedure, the surgeon covered the implant by elevating the tissue locally.

 
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Brand NameBIM400 IMPLANT MAGNET
Type of DeviceCOCHLEAR BAHA ATTRACT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW 435 22
Manufacturer Contact
sujeewa wijesinghe
1 university avenue
macquarie university, nsw 2109,
AS   2109,
MDR Report Key7288141
MDR Text Key100644555
Report Number6000034-2018-00389
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 USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 02/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/05/2021
Device MODEL Number93550
Device Catalogue Number93550
Device LOT Number108997
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/07/2018
Was Device Evaluated By Manufacturer? No
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: 02/22/2018 Patient Sequence Number: 1
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