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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Device Problem Loss of Osseointegration (2408)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Date 02/19/2020
Event Type  Injury  
Manufacturer Narrative
This report is submitted on april 8, 2020.
 
Event Description
Per the clinic, the patient experienced a loss of osseointegration on (b)(6) 2020, resulting in fixture loss. The patient was treated with antibiotic ointment following the loss. Re-implantation is planned; however, yet to occur.
 
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Brand NameNI
Type of DeviceCOCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW 435 22
Manufacturer Contact
roberta loveday
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key9936530
MDR Text Key187023546
Report Number6000034-2020-00989
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/05/2020,04/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/05/2020
Event Location No Information
Date Report to Manufacturer04/15/2020
Date Manufacturer Received04/15/2020
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: 04/08/2020 Patient Sequence Number: 1
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