MAUDE Adverse Event Report: ADVANCED URO-SOLUTIONS, L.L.C.; INSTRUMENT, STEREOTAXIC

Model Number	FM-4010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional via a manufacturer representative regarding a patient with an implantable neurostimulator (ins).It was reported during the procedure the fiducial broke in half when being unscrewed from the skull.No environmental or external factors were reported to have led or contributed to the issue.The second half was removed surgically from the skull.The issue was resolved and the patient was alive without injury at the time of the report.No further complications were reported or anticipated.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis found that the fiducial was broken.If information is provided in the future, a supplemental report will be issued.

• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): ADVANCED URO-SOLUTIONS, L.L.C.; 7842 hickory flat highway; suite d; woodstock GA 30188
• MDR Report Key: 7264316
• Report Number: 3012165443-2018-00002
• Device Sequence Number: 1223613
• Product Code: MHY
• UDI-Device Identifier: 20613994747833
• UDI-Public: 20613994747833
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2019
• Device Model Number: FM-4010
• Device Catalogue Number: FM-4010
• Device Lot Number: 082816016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 02/20/2018; 03/14/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 03/01/2018; 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 153