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	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced skin irritation at the abutment site and subsequently was treated with topical antibiotics (specific date and duration not reported).The patient also underwent a skin revision with silver nitrate.

• 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
• MDR Report Key: 16551010
• Report Number: 6000034-2023-00822
• Device Sequence Number: 3021385
• Product Code: FZE
• UDI-Device Identifier: 09321502021692
• UDI-Public: (01)09321502021692(10)184640(17)240924
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2023
• Report Date (Section F): 03/16/2023

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 Expiration Date: 09/24/2024
• Device Model Number: 92997
• Device Catalogue Number: 92997
• Device Lot Number: 184640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/16/2023