MAUDE Adverse Event Report: RENISHAW MAYFIELD SARL NEUROMATE FRAMELESS GEN II; NEUROMATE FRAMLESS GEN II

Model Number	FRAMELESS GEN II
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 27th of april, this file has been submitted but disappear from the interface while the acknowledgment had not been received.
Event or Problem Description
During a surgery at (b)(6) hospital in (b)(6), a trajectory executed by the robot did not correspond to the planned one.It had a position too anterior regarding the surgeon's planning.The issue was detected by the surgeon before introducing the electrode because the trajectory was clearly not on its planned position.A field service engineer was on site during the surgery.They recreated a trajectory by using its coordinates and the robot reached the correct position without any problem.They failed to reproduce the issue on site.

• Brand Name: NEUROMATE FRAMELESS GEN II
• Common Device Name: NEUROMATE FRAMLESS GEN II
• Manufacturer (Section D): RENISHAW MAYFIELD SARL; 31, rue ampere; chassieu, 69680 ; FR 69680
• MDR Report Key: 6580933
• Report Number: 3009108888-2017-00001
• Device Sequence Number: 16427624
• Product Code: HAW
• UDI-Device Identifier: 03662724000024
• UDI-Public: (01)03662724000024
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K132755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 03/31/2017

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: Other
• Device Model Number: FRAMELESS GEN II
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2017
• Initial Report FDA Received Date: 05/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR