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

Model Number	92997
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on may 26, 2023.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 6000034-2023-01618
• Device Sequence Number: 12651145
• Product Code: FZE
• UDI-Device Identifier: 09321502021692
• UDI-Public: (01)09321502021692(10)194152(17)261119
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K945154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male