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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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/26/2020
Event Type  Injury  
Manufacturer Narrative
This report is submitted on december 3, 2020.
 
Event Description
Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss. It is unknown if there are plans to reimplant the patient with a new device as of the date of this report.
 
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Brand NameFLANGE FIXTURE ST 4MM W. BAHA ABUTMENT
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
weiting zhen
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key10939159
MDR Text Key219301667
Report Number6000034-2020-03386
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
Type of Report Initial
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number90434
Device Catalogue Number90434
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2020
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: 12/03/2020 Patient Sequence Number: 1
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