MAUDE Adverse Event Report: Renishaw Mayfield SARL Neuromate Gen III Stereotactic System

Model Number	neuromate
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the surgery the surgeon reported an inaccuracy 3mm.The trajectory was revised to acceptable accuracy.The patient was successfully treated following a delay to the surgery.The device specification for accuracy is 2mm.This is being reported on the basis of the potential for direct harm if this were to happen on another occasion.

• Brand Name: Neuromate Gen III Stereotactic System
• Common Device Name: Neuromate Gen III
• Manufacturer (Section D): Renishaw Mayfield SARL; 31 rue ampere; chassieu, 69680 ; FR 69680
• Manufacturer (Section G): Renishaw Mayfield SARL; 31 rue ampere; chassieu, 69680 ; FR 69680
• Manufacturer Contact: rusling ; 31 rue ampere; chassieu, 69680 ; FR 69680
• MDR Report Key: 50895694
• Report Number: 3009108888-2026-00008
• Device Sequence Number: 20333704
• Product Code: HAW
• UDI-Device Identifier: 03662724000345
• UDI-Public: 03662724000345
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K181706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: neuromate
• Device Catalogue Number: 001.0500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/25/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown