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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a skin overgrowth on the abutment.Subsequently, the patient underwent a soft tissue reduction surgery under general anesthesia (specific date not reported).The implanted device remains.

• 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: 12801608
• Report Number: 6000034-2021-03462
• Device Sequence Number: 17278842
• Product Code: FZE
• UDI-Device Identifier: 09321502021692
• UDI-Public: (01)09321502021692(10)184640(17)240924
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/24/2021
• Report Date (Section F): 11/12/2021

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: 10/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2021
• 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: 11/12/2021