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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 W. BAHA ABUTMENT COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 90434
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Erosion (1750)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on (b)(6) 2018. (b)(4).

 
Event Description

It was reported that the patient experienced an infection and skin breakdown at the abutment site. Subsequently, the device was explanted (date not reported).

 
Manufacturer Narrative

Correction: the product details reported on the initial report are not correct. The details of the implant fixture are currently unknown. Should the device details become available, a supplementary report shall be submitted.

 
Manufacturer Narrative

No specific device analysis is deemed necessary at this moment. No deviations that explain the reported issue is found. There are no indications that the reported issue is related to any device failure. Previously product examinations have not showed any relationship between a product geometrical deviation and the reported clinical complication. No ocular inspection of the returned product is therefore deemed necessary. ) adverse skin reactions around the baha abutment, ranging from slight redness to infected tissue, as well as excessive skin thickening and skin growing over the abutment are common complications with baha implants. The report frequency for these complications is being monitored under cbas complaint and mdr data monitoring plan and the status is updated on a monthly basis. This event is added to this monitoring. There are no indications that a product failure has contributed to the reported issue (b)(4).

 
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Brand NameFLANGE FIXTURE ST 4MM W. BAHA ABUTMENT
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
Manufacturer (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 43533
SW 43533
Manufacturer Contact
kristel kohne
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key7344047
MDR Text Key102569557
Report Number6000034-2018-00604
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
PMA/PMN NumberK955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Type of Report Initial,Followup,Followup
Report Date 03/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number90434
Device Catalogue Number90434
Device LOT Number113559
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/20/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/28/2018
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/15/2018 Patient Sequence Number: 1
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