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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 BIA300
Device Problem Loss of Osseointegration (2408)
Patient Problem Head Injury (1879)
Event Type  Injury  
Manufacturer Narrative
(b)(4).This report is filed on july 8, 2016, by cochlear ltd.On behalf of cochlear americas.Device not received by manufacturer.
 
Event Description
Per the clinic, the patient experienced a loss of fixture subsequent to sustaining a head trauma (date not reported).Re-implantation is planned; however has yet to occur, as of the date of this report.
 
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Brand Name
FLANGE FIXTURE AND ABUTMENT
Type of Device
LXB
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW  435 22
Manufacturer (Section G)
COCHLEAR AMERICAS
13059 east parkview avenue
centennial CO 80111
Manufacturer Contact
bianca hanlon
1 university avenue
macqaurie university, nsw 2109
AS   2109
2 9428 655
MDR Report Key5777710
MDR Text Key49020068
Report Number6000034-2016-01377
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Audiologist
Type of Report Initial
Report Date 06/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberBIA300
Device Catalogue Number92127
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/28/2016
Date Manufacturer Received06/28/2016
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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