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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR AMERICAS BAHA BA400 ABUTMENT HEARING AID, BONE CONDUCTION, IMPLANTED

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COCHLEAR AMERICAS BAHA BA400 ABUTMENT HEARING AID, BONE CONDUCTION, IMPLANTED Back to Search Results
Catalog Number 93331
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Code Available (3191)
Event Date 02/23/2017
Event Type  Malfunction  
Event Description

Surgeon attempted implantation of the device. The device would not screw in and lock in place. Abutment from device working properly and implanted, new 4mm implant was opened and implanted successfully.

 
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Brand NameBAHA BA400 ABUTMENT
Type of DeviceHEARING AID, BONE CONDUCTION, IMPLANTED
Manufacturer (Section D)
COCHLEAR AMERICAS
13059 e peakview ave.
centennial CO 80111
MDR Report Key6515402
MDR Text Key73478124
Report Number6515402
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/24/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue Number93331
Device LOT NumberCOH1074456
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/05/2017
Event Location Other
Date Report TO Manufacturer04/05/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/24/2017 Patient Sequence Number: 1
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