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 Unspecified Infection (1930); Impaired Healing (2378)

Event Date 06/09/2016

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: keric n, eum d, afghanyar f, rachwal-czyzewicz i, renovanz m, conrad j, wep d, kantelhardt s, giese a.Evaluation of surgical strategy of conventional vs.Percutaneous robot-assisted spinal trans-pedicular instrumentation in spondylodiscitis.Journal of robotic surgery.Doi: 10.1007/s11701-016-0597-5.If information is provided in the future, a supplemental report will be issued.

Event Description

Abstract: robot-assisted percutaneous insertion of pedicle screws is a recent technique demonstrating high accuracy.The optimal treatment for spondylodiscitis is still a matter of debate.We performed a retrospective cohort study on surgical patients treated with pedicle screw/rod placement alone without the application of intervertebral cages.In this collective, we compare conventional open to a further minimalized percutaneous robot-assisted spinal instrumentation, avoiding a direct contact of implants and infectious focus.90 records and ct scans of patients treated by dorsal transpedicular instrumentation of the infected segments with and without decompression and antibiotic therapy were analysed for clinical and radiological outcome parameters.24 patients were treated by free-hand fluoroscopy-guided surgery (121 screws), and 66 patients were treated by percutaneous robot-assisted spinal instrumentation (341 screws).Accurate screw placement was confirmed in 90 % of robot-assisted and 73.5 % of free-hand placed screws.Implant revision due to misplacement was necessary in 4.95 % of the free-hand group compared to 0.58 % in the robot-assisted group.The average intraoperative x-ray exposure per case was 0.94 ± 1.04 min in the freehand group vs.0.4 ± 0.16 min in the percutaneous group (p = 0.000).Intraoperative adverse events were observed in 12.5 % of free-hand placed pedicle screws and 6.1 % of robot robot-assisted screws.The mean postoperative hospital stay in the free-hand group was 18.1 ± 12.9 days, and in percutaneous group, 13.8 ± 5.6 days (p = 0.012).This study demonstrates that the robot-guided insertion of pedicle screws is a safe and effective procedure in lumbar and thoracic spondylodiscitis with higher accuracy of implant placement, lower radiation dose, and decreased complication rates.Percutaneous spinal dorsal instrumentation seems to be sufficient to treat lumbar and thoracic spondylodiscitis.Reported events: 4 patients being treated for spondylodiscitis using the robotic guidance system experienced wound healing abnormalities and infection.All of the patients required a revision surgery.2 patients being treated for spondylodiscitis using the robotic guidance system had to have a revision due to misplaced screws.4 patients being treated for spondylodiscitis using the robotic guidance system had to have a revision due to loosened screws.

• 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: 8904446
• MDR Text Key: 156180963
• Report Number: 1723170-2019-04514
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K120812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2019
• 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: 10/12/2018
• 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