• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 10MM COCHLEAR BAHA CONNECT SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 10MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 93331
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Date 11/17/2016
Event Type  Injury  
Manufacturer Narrative

This report is submitted on december 15, 2016. (b)(4).

 
Event Description

Per the clinic, the patient experienced pain at abutment site, subsequently the device was explanted on (b)(6) 2016. It is unknown if there are plans to re-implant the patient with a new device as of the date of this report.

 
Manufacturer Narrative

Correction: the initial mdr submitted on december 15, 2016 was filed inadvertently, no explant occurred. The patient experienced a loss of osseointegration, resulting in fixture loss. (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIA400 IMPLANT 4MM W ABUTMENT 10MM
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
kristel kohne
1 university avenue
macqaurie university, nsw 2109
AS   2109
94286555
MDR Report Key6176033
MDR Text Key62426476
Report Number6000034-2016-02566
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeEI
PMA/PMN NumberK121317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/03/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/15/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number93331
Device Catalogue Number93331
Device LOT NumberCOH784997
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2016
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

Patient TREATMENT DATA
Date Received: 12/15/2016 Patient Sequence Number: 1
-
-