MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 4.5MM; COCHLEAR BAHA VISTAFIX SYSTEM

Model Number 92995

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Impaired Healing (2378)

Event Date 05/17/2022

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a skin overgrowth on the abutment.Subsequently, the patient underwent a revision surgery under general anesthesia on (b)(6) 2022, in order to remove the abutment.

• Brand Name: COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 4.5MM
• 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: 14786021
• MDR Text Key: 294566503
• Report Number: 6000034-2022-01837
• Device Sequence Number: 1
• Product Code: FZE
• UDI-Device Identifier: 09321502021678
• UDI-Public: (01)09321502021678(10)155997(17)200630
• 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
• Report Date: 06/23/2022,06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2020
• Device Model Number: 92995
• Device Catalogue Number: 92995
• Device Lot Number: 155997
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2022
• Distributor Facility Aware Date: 06/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Sex: Female