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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA210 FLANGE FIXTURE ST 3MM W ABUTMENT 5.5MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA210 FLANGE FIXTURE ST 3MM W ABUTMENT 5.5MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92134
Device Problems Appropriate Term/Code Not Available (3191); Missing Value Reason (3192)
Patient Problem Bacterial Infection (1735)
Event Date 11/14/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). This report is filed on october 12, 2016. Implanted device remains.

 
Event Description

Per the clinic, the patient developed infection at abutment site, however the issue could not be resolved; subsequently the patient was treated with oral and topical antibiotics (date and duration not reported). The implanted device remains.

 
Manufacturer Narrative

Per the clinic, the patient underwent revision surgery on (b)(6) 2016, in order to place an internal magnet. The implanted device remains. (b)(4).

 
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Brand NameBIA210 FLANGE FIXTURE ST 3MM W ABUTMENT 5.5MM
Type of DeviceCOCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke 435 33, 435 2 2
SW 435 22
Manufacturer (Section G)
COCHLEAR AMERICAS
13059 east peakview avenue
centennial, co 80111
Manufacturer Contact
pavana nayak
1 university avenue
macquarie university, nsw 2109
AS   2109
2 9428 655
MDR Report Key6019626
MDR Text Key57044157
Report Number6000034-2016-02005
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/18/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/11/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92134
Device Catalogue Number92134
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date11/18/2016
Event Location No Information
Date Manufacturer Received11/18/2016
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 Initial

Patient TREATMENT DATA
Date Received: 10/11/2016 Patient Sequence Number: 1
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