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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT LXB

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COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT LXB Back to Search Results
Model Number BIA210
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

The date of initial implantation is unknown per the date of this report. This report is filed on july 6, 2016. (b)(4). Implanted device remains.

 
Event Description

Per the clinic, the patient experienced a chronic infection with granulation tissue at the implant site. The issue could not be resolved, and the patient was subsequently placed under general anesthesia in order to remove the abutment on (b)(6) 2016. The implanted device remains.

 
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Brand NameFLANGE FIXTURE AND ABUTMENT
Type of DeviceLXB
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW 435 22
Manufacturer (Section G)
COCHLEAR AMERICAS
13059 east parkview avenue
centennial CO 80111
Manufacturer Contact
bianca hanlon
1 university avenue
macqaurie university, nsw 2109
AS   2109
2 9428 655
MDR Report Key5771257
MDR Text Key48816454
Report Number6000034-2016-01331
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 06/24/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/05/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberBIA210
Device Catalogue Number32135
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date06/24/2016
Event Location No Information
Date Manufacturer Received06/24/2016
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: 07/05/2016 Patient Sequence Number: 1
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