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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
Catalog Number 90422
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Host-Tissue Reaction (1297); Device Embedded In Tissue or Plaque (3165)
Event Date 01/04/2016
Event Type  Injury  
Manufacturer Narrative

This report is filed january 14, 2016.

 
Event Description

Per the clinic, the patient developed a soft tissue reaction at the vistafix implant site. Treatment with antibiotics (type and duration not reported) was unsuccessful. 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 Contact
bianca hanlon
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key5368301
MDR Text Key36011238
Report Number6000034-2016-00152
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeHR
PMA/PMN NumberK955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 01/04/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/14/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device Catalogue Number90422
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2016
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: 01/14/2016 Patient Sequence Number: 1
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