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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92130
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Host-Tissue Reaction (1297)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on november 7, 2017, (b)(4).

 
Event Description

Per the clinic, the patient experienced soft tissue complications at the implant site. Subsequently, the patient was treated with oral and topical antibiotics (date and duration not reported); however, the patient continued to experienced skin overgrowth issues. Revision surgery is scheduled; however, yet to occur as of the date of this report.

 
Manufacturer Narrative

Per the clinic, the patient underwent revision surgery on (b)(6) 2017 in order to excise infected tissue at the abutment site and have a magnet placed on the internal fixture, converting the patient to a subcutaneous baha implant system.

 
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Brand NameBA300 ABUTMENT 6MM
Type of DeviceCOCHLEAR BAHA CONNECT 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
kristel kohne
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key7005423
MDR Text Key91182612
Report Number6000034-2017-01995
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberASKU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation AUDIOLOGIST
Type of Report Initial,Followup
Report Date 12/01/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92130
Device Catalogue Number92130
Device LOT NumberN/I
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/01/2017
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: 11/06/2017 Patient Sequence Number: 1
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