MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC RENAISSANCE SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number TPL0038

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Complaint, Ill-Defined (2331); Spinal Cord Injury (2432)

Event Date 08/12/2017

Event Type  Injury  

Manufacturer Narrative

Please note that this date is based off the date of publication of the article as the actual event date was not provided.The reported event was from the following literature article: laratta j, shillingford j, lombardi j, alrabaa r, benkli b, fischer c, lenke l, lehman r.Accuracy of s2 alar-iliac screw placement under robotic guidance.Spine deformity.Spine deformity.6 (2018).Doi.Org/10.1016/j.Jspd.2017.08.009.If information is provided in the future, a supplemental report will be issued.

Event Description

Abstract: to determine the safety and feasibility of s2 alar-iliac (s2ai) screw placement under robotic guidance.Similar to standard iliac fixation, s2ai screws aid in achieving fixation across the sacropelvic junction and decreasing s1 screw strain.Fortunately, the s2ai technique minimizes prominent instrumentation and the need for offset connectors to the fusion construct.Herein, we present an analysis of the largest series of robotic-guided s2ai screws in the literature without any significant author conflicts of interest with the robotics industry.Twenty-three consecutive patients who underwent spinopelvic fixation with 46 s2ai screws under robotic guidance were analyzed from 2015 to 2016.Screws were placed by two senior spine surgeons, along with various fellow or resident surgical assistants, using a proprietary robotic guidance system.Screw position and accuracy was assessed on intraoperative ct o-arm scans and analyzed using three-dimensional interactive viewing and manipulation of the images.The average caudal angle in the sagittal plane was 31.0 10.0.The average horizontal angle in the axial plane using the posterior superior iliac spine as a reference was 42.8 6.6.The average s1 screw to s2ai screw angle was 11.3 9.9.Two violations of the iliac cortex were noted, with an average breach distance of 7.9 4.8 mm.One breach was posterior (2.2%) and one was anterior (2.2%).The overall robotic s2ai screw accuracy rate was 95.7%.There were no intraoperative neurologic, vascular, or visceral complications related to the placement of the s2ai screws.Spinopelvic fixation achieved using a bone-mounted miniature robotic-guided s2ai screw insertion technique is safe and reliable.Despite two breaches, no complications related to the placement of the s2ai screws occurred in this series.Reported events: two patients being operated on with the robotic guidance system experienced incidental durotomies that were recognized intraoperatively and repaired.One patient being operated on with the robotic guidance system experienced an epidural hematoma that required surgical re-exploration during the initial hospital admission.One patient being operated on with the robotic guidance system developed an early pseudarthrosis after attempted l4-s1 fusion, which required a revision procedure to l3.

• Brand Name: RENAISSANCE 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: 8905511
• MDR Text Key: 154730009
• Report Number: 1723170-2019-04517
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TPL0038
• Device Catalogue Number: TPL0038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2019
• 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