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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 90434
Device Problem Loss of Osseointegration (2408)
Patient Problem Deafness (1801)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on november 18, 2016.(b)(4).Device not received by manufacturer.
 
Event Description
Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss (date not reported).Subsequent to the loss of fixture, the patient was treated with a steroid ointment.
 
Manufacturer Narrative
Per the clinic, it was reported that prior to the loss of osseointegration, the patient experienced and infection at the implant site.This report is submitted january 18, 2017.
 
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Brand Name
FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT
Type of Device
COCHLEAR 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
bianca hanlon
1 university avenue
macqaurie university, nsw 2109
AS   2109
2 9428 655
MDR Report Key6111883
MDR Text Key60280966
Report Number6000034-2016-02260
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K955713
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 12/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number90434
Device Catalogue Number90434
Device Lot Number608583
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/05/2016
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) Other; Required Intervention;
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