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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 4MM W ABUTMENT 5.5MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA210 FLANGE FIXTURE ST 4MM W ABUTMENT 5.5MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92135
Device Problem Loss of Osseointegration (2408)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss. Reimplantation is planned but has not taken place at the time of this report.
 
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Brand NameBIA210 FLANGE FIXTURE ST 4MM 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 Key11043493
MDR Text Key222620007
Report Number6000034-2020-03504
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 12/21/2020,12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number92135
Device Catalogue Number92135
Device Lot NumberCOH141632
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/21/2020
Distributor Facility Aware Date12/02/2020
Event Location No Information
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: 12/20/2020 Patient Sequence Number: 1
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