MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVIGATION STEALTH STATION S7 SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9733856

Device Problem Imprecision (1307)

Patient Problem Nerve Damage (1979)

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

Patient identifier and weight currently not known at the time of filing.A medtronic representative went to the site to test the equipment.Testing revealed that the navigation system functioned as designed.The system then passed the system checkout and was found to be fully functional.Analysis on the software resulted to be inconclusive and was unable to determine a probable cause since the behavior cannot be duplicated.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported that intra/peri-operatively during the navigate task of a l4-l5 tlif sacroiliac and thoracolumbar procedure, the surgeon alleged inaccuracy of approximately 2mm with the system.After placing the l4 screws, they looked good on the system, but then upon verification, the screws were low in the vertebral body.Two screws had to be re-positioned.The patient had a nerve deficit post-op.A spine representative was present.There was no delay to the procedure.There was an impact to the patient due to the nerve damage.

Manufacturer Narrative

Correction: patient id and patient weight were not sent with the initial report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NAVIGATION STEALTH STATION S7 SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7934665
• MDR Text Key: 122685919
• Report Number: 1723170-2018-04986
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 139