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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 Appropriate Term/Code Not Available (3191)
Patient Problem Host-Tissue Reaction (1297)
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

Per the audiologist, it was reported that the patient experienced a skin overgrowth at the abutment site and was administered a steroid injection (date not reported). Subsequently, the patient underwent revision surgery (date not reported), in order to convert the patient to a percutaneous baha implant system. During the procedure, the abutment was removed and a magnet was placed on the internal fixture.

 
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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
Manufacturer (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke 43533
SW 43533
Manufacturer Contact
tamara martin
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key8224744
MDR Text Key132333383
Report Number6000034-2018-02474
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK984162
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 12/13/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/07/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number90432
Device Catalogue Number90432
Device LOT Number607337
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 01/07/2019 Patient Sequence Number: 1
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