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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 9MM COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 9MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92131
Device Problem Missing Value Reason (3192)
Patient Problem Foreign Body Reaction (1868)
Event Type  Injury  
Manufacturer Narrative

Additional information regarding the product details were requested; however, not made available as of the date of this report. This report is submitted on march 7, 2017. (b)(4).

 
Event Description

Per the clinic, the patient sustained a trauma to the implant site, resulting in displacement of the abutment. Subsequently, the patient developed adverse skin reactions and granulomas that required revision. On (b)(6) 2017, the device was explanted in order to allow for the site to heal.

 
Manufacturer Narrative

Correction: no explantation has occurred. The abutment was removed and subsequently the patient was treated with a steroid injection. The implanted device remains. This report is submitted on april 18, 2017.

 
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Brand NameBA300 ABUTMENT 9MM
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 Contact
sujeewa wijesinghe
1 university avenue
macqaurie university, nsw 2109
AS   2109
94286555
MDR Report Key6382574
MDR Text Key69202520
Report Number6000034-2017-00497
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeCO
PMA/PMN NumberK100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup
Report Date 02/14/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92131
Device Catalogue Number92131
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/04/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2017
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

Patient TREATMENT DATA
Date Received: 03/06/2017 Patient Sequence Number: 1
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