• 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 BI300 IMPLANT 4 MM 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 BI300 IMPLANT 4 MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92129
Device Problem Loss of Osseointegration (2408)
Patient Problem Fistula (1862)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on april 4, 2019. (b)(4).

 
Event Description

Per the clinic, the patient experienced a fistula and a loss of osseointegration. Subsequently, the patient was hospitalised on (b)(6) 2019 and the device was explanted on (b)(6) 2019, under general anaesthetic.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBI300 IMPLANT 4 MM
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 (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke 43533
SW 43533
Manufacturer Contact
tamara martin
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key8481150
MDR Text Key140872398
Report Number6000034-2019-00476
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 03/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92129
Device Catalogue Number92129
Device LOT NumberCOH1117229
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2019
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: 04/03/2019 Patient Sequence Number: 1
-
-