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  

Manufacturer Narrative

This report is submitted on may 26, 2023.

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.

Manufacturer Narrative

Correction: the initial mdr submitted on may 26, 2023, was filed inadvertently.There was no skin revision.This report is submitted on june 23, 2023.

• 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
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: aini yusof ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17008873
• MDR Text Key: 315990616
• Report Number: 6000034-2023-01618
• 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
• PMA/PMN Number: K945154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male