MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CRANIAL REFERENCE FRAME; INSTRUMENT, STEREOTAXIC

Model Number	961-337
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cranial reference frame was returned to the manufacturer for analysis.Analysis found that the frame was in good condition and functioned as expected.No fault was found.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that during the verify task of a cervical spine procedure, one of the sphere posts were bent on the cranial reference frame and causing tracking issues.The site replaced the cranial frame with a new reference frame and there were no issues tracking.This caused a 5 minute delay to surgery.There was no reported impact on patient outcome.

• Brand Name: CRANIAL REFERENCE FRAME
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7974872
• Report Number: 1723170-2018-05194
• Device Sequence Number: 1739183
• Product Code: HAW
• UDI-Device Identifier: 00721902467783
• UDI-Public: 00721902467783
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• 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
• Report Date (Section B): 10/17/2018

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: 961-337
• Device Catalogue Number: 961-337
• Device Lot Number: 170421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 87