MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 7.5MM; COCHLEAR BAHA VISTAFIX SYSTEM

Model Number 92997

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced swelling at the abutment site.Subsequently, the patient underwent a skin revision surgery (specific date not reported) in order to expose the abutment area and to place a larger cap, however, it was unsuccessful.The implanted device remains.Additional information has been requested but it has not been made available as of the date of this report.

Event Description

Correction: the initial mdr submitted on may 26, 2023, was filed inadvertently.There was no skin revision.

• Brand Name: COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 7.5MM
• Type of Device: COCHLEAR BAHA VISTAFIX SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 17008874
• MDR Text Key: 315990620
• Report Number: 6000034-2023-01619
• Device Sequence Number: 1
• Product Code: FZE
• UDI-Device Identifier: 09321502021692
• UDI-Public: (01)09321502021692(10)194152(17)261119
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2023,05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 92997
• Device Catalogue Number: 92997
• Device Lot Number: 194152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2023
• Distributor Facility Aware Date: 05/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male