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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 93332
Device Problem Loss of Osseointegration (2408)
Patient Problem Head Injury (1879)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on october 02, 2018, (b)(4).

 
Event Description

Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss subsequent to sustaining a head trauma. There are plans to reimplant the patient with a new device; however this has not occurred as of the date of this report october 02, 2018.

 
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Brand NameBIA400 IMPLANT 4MM W ABUTMENT 12MM
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
sujeewa wijesinghe
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key7925017
MDR Text Key122296331
Report Number6000034-2018-01997
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 USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 09/23/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2018
Device MODEL Number93332
Device Catalogue Number93332
Device LOT Number131831
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2018
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 TREATMENT DATA
Date Received: 10/02/2018 Patient Sequence Number: 1
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