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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 90432
Device Problem Loss of Osseointegration (2408)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/27/2020
Event Type  Injury  
Event Description
Per the clinic, it was reported that the patient experienced a loss of osseointegration resulting in fixture loss on (b)(6) 2020. It is unknown whether there are plans to reimplant the patient as of the date of this report.
 
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Brand NameFLANGE FIXTURE ST 4MM
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 Key9881618
MDR Text Key185970443
Report Number6000034-2020-00948
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 03/26/2020,03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number90432
Device Catalogue Number90432
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/26/2020
Distributor Facility Aware Date03/02/2020
Event Location Hospital
Date Report to Manufacturer03/26/2020
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: 03/25/2020 Patient Sequence Number: 1
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