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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA210 FLANGE FIXTURE ST 3MM W ABUTMENT 5.5MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA210 FLANGE FIXTURE ST 3MM W ABUTMENT 5.5MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92134
Device Problem Loss of Osseointegration (2408)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on 10 may 2021.

 
Event Description

Per the clinic, the patient experienced an infection and a loss of osseointegration. There are plans to convert the patient to a transcutaneous osia implant system but has not been performed as of the date of this report.

 
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Brand NameBIA210 FLANGE FIXTURE ST 3MM W ABUTMENT 5.5MM
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 LIMITED
1 university avenue
macquarie university
nsw 2109
AS 2109
Manufacturer Contact
durga velayutham
unit ug-1, vertical podium
no.8 jalan kerinchi,
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key11810753
MDR Text Key250180250
Report Number6000034-2021-01282
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 04/14/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/12/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92134
Device Catalogue Number92134
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2021
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: 05/12/2021 Patient Sequence Number: 1
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