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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92128
Device Problem Loss of Osseointegration (2408)
Patient Problem No Code Available (3191)
Event Date 04/06/2020
Event Type  Injury  
Manufacturer Narrative
This report is submitted on may 18, 2020.
 
Event Description
Per the clinic, the patient experienced a loss of osseointegration resulting in fixture loss. It is unknown if the patient was re-implanted with another device as of the date of this report.
 
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Brand NameBI300 IMPLANT 3MM
Type of DeviceCOCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 3 3
SW 435 33
Manufacturer (Section G)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS 2109
Manufacturer Contact
ken yian chow
unit ug-1 vertical podium
no. 8 jalan kerinchi
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key10064118
MDR Text Key191250804
Report Number6000034-2020-01258
Device Sequence Number1
Product Code LXB
UDI-Device Identifier09321502019538
UDI-Public(01)09321502019538(10)COH1129964(17)220815
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
K100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/15/2022
Device Model Number92128
Device Catalogue Number92128
Device Lot NumberCOH1129964
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/05/2017
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: 05/17/2020 Patient Sequence Number: 1
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