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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 93332
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Host-Tissue Reaction (1297)
Event Type  Injury  
Manufacturer Narrative

Registration number (b)(4).

 
Event Description

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

 
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Brand NameBIA400 IMPLANT 4MM W ABUTMENT 12MM
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
sujeewa wijesinghe
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key7964089
MDR Text Key123667646
Report Number6000034-2018-02040
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeCO
PMA/PMN NumberK121317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 10/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2019
Device MODEL Number93332
Device Catalogue Number93332
Device LOT Number158806
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2018
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: 10/15/2018 Patient Sequence Number: 1
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