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

Model Number 92995

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2022

Event Type  Injury  

Event Description

Per the clinic, the patient was placed under general anesthesia (specific date not reported) 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: 14775390
• MDR Text Key: 294511151
• Report Number: 6000034-2022-01822
• Device Sequence Number: 1
• Product Code: FZE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/22/2022,05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 92995
• Device Catalogue Number: 92995
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2022
• Distributor Facility Aware Date: 05/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention