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	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer investigated on site on the 22th of september.The neuromate system is accurate and within its specifications.The investigation of the cause is still under process.
Event or Problem Description
During a surgery at (b)(6) hospital, some trajectories were estimated outside the accuracy specification of the product.The estimation of the error by the surgeon is 4-5 mm.While, the error should be within 3mm.Initial feedback from the treating surgeon confirmed that the patient is doing fine and there is no evidence of haemorrhage on the post operation ct scan.

• 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: 6893008
• Report Number: 3009108888-2017-00002
• Device Sequence Number: 636753
• Product Code: HAW
• UDI-Device Identifier: 03662724000024
• UDI-Public: (01)03662724000024
• Combination Product (Y/N): N
• 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: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/26/2017

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR