MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problem Imprecision (1307)

Patient Problems Spinal Column Injury (2081); Iatrogenic Source (2498)

Event Date 11/03/2016

Event Type  Injury  

Manufacturer Narrative

Patient information was not made available from the site.No parts have been received by manufacturer for analysis.No further issues have been reported.Part not received by manufacturer.

Event Description

A medtronic representative reported that, while in a spine procedure, the surgeon alleged an inaccuracy of 1 centimeter occurred when navigating.The surgeon checked screw placement at the end of the procedure and multiple screws were determined to be misplaced.The specific number of misplaced screws was not provided, nor was it reported if the surgeon re-positioned any screws no further details were provided.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy reported.There was no impact on patient outcome.

Manufacturer Narrative

Patient information now provided.Patient age not available from the site.The site declined a service visit from a medtronic representative.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 6143447
• MDR Text Key: 61399027
• Report Number: 1723170-2016-05612
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 83