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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA210 FLANGE FIXTURE ST 3MM W ABUTMENT 5.5MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA210 FLANGE FIXTURE ST 3MM W ABUTMENT 5.5MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92134
Device Problem Loss of Osseointegration (2408)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Event Description

Per the clinic, the patient experienced an infection and a loss of osseointegration. There are plans to convert the patient to a transcutaneous osia implant system but has not been performed as of the date of this report.

 
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Brand NameBIA210 FLANGE FIXTURE ST 3MM W ABUTMENT 5.5MM
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 Key11810750
MDR Text Key250180034
Report Number6000034-2021-01283
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
Type of Report Initial
Report Date 05/10/2021,04/14/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/12/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92134
Device Catalogue Number92134
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/10/2021
Distributor Facility Aware Date04/14/2021
Event Location No Information
Date Report TO Manufacturer05/10/2021
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: 05/12/2021 Patient Sequence Number: 1
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