• 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 BIA300 IMPLANT 4MM W ABUTMENT 9MM 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 BIA300 IMPLANT 4MM W ABUTMENT 9MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92346
Device Problem Loss of Osseointegration (2408)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/05/2021
Event Type  Injury  
Manufacturer Narrative

This report is submitted on april 29, 2021.

 
Event Description

Per the clinic, the patient experienced a loss of osseointegration on (b)(6) 2021, 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIA300 IMPLANT 4MM W ABUTMENT 9MM
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 Key11742967
MDR Text Key247899476
Report Number6000034-2021-01157
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 04/05/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92346
Device Catalogue Number92346
Device LOT NumberCOH1306447
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2021
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: 04/28/2021 Patient Sequence Number: 1
-
-