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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

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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on february 12, 2021.
 
Event Description
Per the clinic, the patient experienced a loss of osseointegration of the implant (caught his abutment on his sweatshirt when undressing and pulled the complete implant and abutment from his head. There was no indication of an infection. It is unknown if there are plans to re-implant the patient with another device.
 
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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
MDR Report Key11319409
MDR Text Key231575766
Report Number6000034-2021-00411
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/12/2021,01/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number92346
Device Catalogue Number92346
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/12/2021
Distributor Facility Aware Date01/20/2020
Event Location No Information
Date Report to Manufacturer01/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/11/2021 Patient Sequence Number: 1
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