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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
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 30 sep 2020.

 
Event Description

Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss. There are no plans to reimplant the patient with a new device as of the date of this report.

 
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Brand NameNI
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 Key10604121
MDR Text Key209147525
Report Number6000034-2020-02591
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 09/30/2020,09/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/30/2020
Distributor Facility Aware Date09/09/2020
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: 09/29/2020 Patient Sequence Number: 1
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