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

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.

• Brand Name: BAHA BA400 ABUTMENT
• Type of Device: HEARING AID, BONE CONDUCTION, IMPLANTED
• Manufacturer (Section D): COCHLEAR AMERICAS; 13059 e peakview ave.; centennial CO 80111
• MDR Report Key: 6515402
• MDR Text Key: 73478124
• Report Number: 6515402
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• 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 Received: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/29/2021
• Device Catalogue Number: 93331
• Device Lot Number: COH1074456
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2017
• Event Location: Other
• Date Report to Manufacturer: 04/05/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR