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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 6MM COCHLEAR BAHA ATTRACT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 6MM COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Model Number 93550
Device Problem Extrusion (2934)
Patient Problem No Code Available (3191)
Event Date 05/31/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

Per the clinic, the patient experienced extrusion of the internal magnet resulting in the decision to explant the device on (b)(6) 2017. The patient was reimplanted on the contralateral side.

 
Manufacturer Narrative

The reported adverse event is associated with a returned device; however, the provided clinical information was reviewed by the manufacturer and no specific device analysis is deemed necessary at this time. Previous product examinations have not showed any relationship between a product geometrical deviation and the reported clinical complication. Additionally, there are no indications that a product failure has contributed to the reported issue.

 
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Brand NameBIA300 IMPLANT 4MM W ABUTMENT 6MM
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 (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 43533
SW 43533
Manufacturer Contact
bianca pries
1 university avenue
macqaurie university, nsw 2109
AS   2109
94286555
MDR Report Key6645931
MDR Text Key77697496
Report Number6000034-2017-01219
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
PMA/PMN NumberK131240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Type of Report Initial,Followup
Report Date 08/09/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/16/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number93550
Device Catalogue Number93550
Device LOT Number117604
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/09/2017
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/09/2017
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: 06/16/2017 Patient Sequence Number: 1
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