MAUDE Adverse Event Report: RADIONICS RADIONICS STEREOTACTIC FRAME; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Device Problem Failure to Align (2522)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported one patient had the procedure aborted as a result of stereotactic frame misalignment (radionics stereotactic frame).(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RADIONICS STEREOTACTIC FRAME
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): RADIONICS
• MDR Report Key: 17529578
• MDR Text Key: 321252176
• Report Number: MW5136502
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1