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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92996
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 07/22/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Per the clinic, the recipient is no longer wear the prosthesis.Reportedly, he experienced an infection.The surgeon is planning to remove the abutment.(date not confirmed).
 
Manufacturer Narrative
Per the clinic, the abutment was removed on (b)(6) 2019 due to non-use.The recipient is no longer wishes to wear the device.Infection is not the reason for removal.Previous infections were treated with antibiotics (type not reported).
 
Event Description
Per the clinic, the abutment was removed on (b)(6) 2019 due to non-use.The recipient is no longer wishes to wear the device.Infection is not the reason for removal.Previous infections were treated with antibiotics (type not reported).
 
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Brand Name
COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 6MM
Type of Device
COCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW  435 22
MDR Report Key8844359
MDR Text Key152749449
Report Number6000034-2019-01380
Device Sequence Number1
Product Code FZE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 07/31/2019,07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number92996
Device Catalogue Number92996
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/31/2019
Distributor Facility Aware Date07/09/2019
Event Location Home
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age19 YR
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