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

Model Number S7

Device Problem Imprecision (1307)

Patient Problem Injury (2348)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

Patient weight not available from the site.A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The software investigation found that a probable cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.

Event Description

A medtronic representative reported that, while in a l2 to s1 spinal fusion, the site observed an imprecision.The site reported the imprecision occurred with the initial screws placed.The site elected to continue with the procedure after taking a second spin.A confirmation image acquisition found that the first screws placed were 1-1.5cm inferior and required revision.The screws were revised still minimally invasive with fluoro image acquisitions.No additional information was provided.There was a reported delay to the procedure of less than 1 hour due to this issue.

Manufacturer Narrative

Correction: the reported incident caused a surgical delay of one hour or longer.A medtronic representative reported that, although unconfirmed, the potential causes were either the bed (axis jackson table) was flexed at some point, which may have impacted anatomy in lower lumbar region; or possibly the reference frame was bumped between spin 1 and 2.

• 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: amos jarrette ; 826 coal creek circle; attn:product quality experienc; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6602841
• MDR Text Key: 76324796
• Report Number: 1723170-2017-02239
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/09/2017

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
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 05/31/2017
• Supplement Dates Manufacturer Received: 08/09/2017
• Supplement Dates FDA Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2016
• 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 Age: 68 YR