MAUDE Adverse Event Report: CLEARPOINT NEURO CLEARPOINT NAVIGATION SYSTEM

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/09/2020

Event Type  malfunction  

Event Description

Upon removal of the clearpoint navigation device from the pt, it was noted that approx 3 mm of one of the mounting screws was broken and remained in the pt's skull.

• Brand Name: CLEARPOINT NAVIGATION SYSTEM
• Type of Device: NAVIGATION SYSTEM
• Manufacturer (Section D): CLEARPOINT NEURO ; 5 musick avenue; irvine CA 92618
• MDR Report Key: 10779084
• MDR Text Key: 214593875
• Report Number: 10779084
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2020
• Distributor Facility Aware Date: 10/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 64