MAUDE Adverse Event Report: MAZOR ROBOTICS LTD MAZOR X SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number TPL0059

Device Problems Imprecision (1307); Use of Device Problem (1670)

Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Unspecified Nervous System Problem (4426)

Event Date 10/13/2021

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: khan a, soliman m, lee n, waqas m, lombardi j, boddapati v, levy l, mao j, park p, mathew j, lehman r, mullin j, pollina j.Ct-to-fluoroscopy registration versus scan-and-plan registration for robot-assisted insertion of lumbar pedicle screws.Neurosurgical focus.2022.52 (1) e8.Doi: 10.3171/2021.10.Focus21506.If information is provided in the future, a supplemental report will be issued.

Event Description

Abstract: pedicle screw insertion for stabilization after lumbar fusion surgery is commonly performed by spine surgeons.With the advent of navigation technology, the accuracy of pedicle screw insertion has increased.Robotic guidance has revolutionized the placement of pedicle screws with 2 distinct radiographic registration methods, the scan and plan method and ct-to-fluoroscopy method.In this study, the authors aimed to compare the accuracy and safety of these methods.A retrospective chart review was conducted at 2 centers to obtain operative data for consecutive patients who underwent robot-assisted lumbar pedicle screw placement.The newest robotic platform (mazor x robotic system) was used in all cases.One center used the scan-and-plan registration method, and the other used ct-to-fluoroscopy for registration.Screw accuracy was determined by applying the gertzbein-robbins scale.Fluoroscopic exposure times were collected from radiology reports.Overall, 268 patients underwent pedicle screw insertion, 126 patients with scan-and-plan registration and 142 with ct-to-fluoroscopy registration.In the scan-and-plan cohort, 450 screws were inserted across 266 spinal levels (mean 1.7 ± 1.1 screws/level), with 446 (99.1%) screws classified as gertzbein-robbins grade a (within the pedicle) and 4 (0.9%) as grade b (<(><<)> 2-mm deviation).In the ct-to-fluoroscopy cohort, 574 screws were inserted across 280 lumbar spinal levels (mean 2.05 ± 1.7 screws/ level), with 563 (98.1%) grade a screws and 11 (1.9%) grade b (p = 0.17).The scan-and-plan cohort had non-significantly less fluoroscopic exposure per screw than the ct-to-fluoroscopy cohort (12 ± 13 seconds vs 11.1 ± 7 seconds, p = 0.3).Both scan-and-plan registration and ct-to-fluoroscopy registration methods were safe, accurate, and had similar fluoroscopy time exposure overall.Reported event: 1 - after use of the guidance system to place screws using ct-flouro registration, four patients experienced surgical site infection.2 - after use of the guidance system to place screws using ct-flouro registration, three patients experienced post-op neurological deficits.3 - after use of the guidance system to place screws using ct-flouro registration, 19 patients experienced dural tears.4 - after use of the guidance system to place screws using ct-flouro registration, 11 screws were deviated less than 2 mm.All of the screws were repositioned during the procedure so they were accurately placed.

• Brand Name: MAZOR X SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IS 3079567
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IS 3079567
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13658409
• MDR Text Key: 286513536
• Report Number: 3005075696-2022-00021
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2022

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: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 03/03/2022
• 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): Other