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

Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): RADIONICS
• MDR Report Key: 17529578
• Report Number: MW5136502
• Device Sequence Number: 5530213
• Product Code: HAW
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown