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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 N/A
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

This report is filed, june 7, 2016. The implanted device remains.

 
Event Description

Per the clinic, the patient developed an infection at the implant site. On (b)(6) 2016 the patient was prescribed a ten day course of oral antibiotics. The patient is also using a topical ointment at the site. The implanted device remains.

 
Manufacturer Narrative

Correction; the correct catalog number is 93335; not 93329 as previously reported. Per the clinic, the patient experienced granulation tissue at the abutment site. Subsequently on (b)(6) 2016, the patient underwent a surgical procedure and the excess tissue was excised. During the same procedure, the abutment was removed and a cover screw was placed. 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, se 435-2 2
SW 435-22
Manufacturer Contact
angel wright
13059 east peakview avenue
centennial, CO 80111
3037909010
MDR Report Key5704799
MDR Text Key46760323
Report Number6000034-2016-01153
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,Followup
Report Date 06/16/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/07/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberN/A
Device Catalogue Number93335
Device LOT Number142430
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 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: 06/07/2016 Patient Sequence Number: 1
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