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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: PRODUCT CODE

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COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE AND ABUTMENT LXB: PRODUCT CODE Back to Search Results
Catalog Number 90432
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative

The implanted device remains.

 
Event Description

Per the clinic, the patient developed granulation tissue and infection at the abutment site. The abutment was removed in office (date not reported) and the site was allowed time to heal. Subsequently on (b)(6) 2016 the patient was administered general anesthesia to facilitate skin excision and placement of new abutment. The implanted device remains.

 
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Brand NameFLANGE FIXTURE AND ABUTMENT
Type of DeviceLXB: PRODUCT CODE
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvagen 14
po box 82
moinlycke SE-43 5 22
SW SE-435 22
Manufacturer Contact
nicole hille
13059 east peakview ave
centennial, CO 80111
3037909010
MDR Report Key5707160
MDR Text Key46834814
Report Number6000034-2016-01190
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 05/25/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/08/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue Number90432
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2016
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/08/2016 Patient Sequence Number: 1
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