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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM WITH BA400 ABUTMENT 10MM COCHLEAR BAHA VISTAFIX SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM WITH BA400 ABUTMENT 10MM COCHLEAR BAHA VISTAFIX SYSTEM Back to Search Results
Model Number 92128 & 93335
Device Problem Loss of Osseointegration (2408)
Patient Problem Hearing Impairment (1881)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Per the clinic, abscess presented on (b)(6) 2019 around recipient's abutment and it was treated with oral and topical antibiotics. The recipient experienced loss of osseointegration on (b)(6) 2019 and the clinic will consider reimplantation in 6 months.
 
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Brand NameBI300 IMPLANT 3MM WITH BA400 ABUTMENT 10MM
Type of DeviceCOCHLEAR BAHA VISTAFIX 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
43533
SW 43533
Manufacturer Contact
yi feng
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key9001006
MDR Text Key158770183
Report Number6000034-2019-01776
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
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 09/12/2019,08/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number92128 & 93335
Device Catalogue Number92128 & 93335
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/12/2019
Distributor Facility Aware Date08/28/2019
Event Location Hospital
Date Manufacturer Received08/28/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 09/12/2019 Patient Sequence Number: 1
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