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 Problem Erosion (1750)

Event Date 01/01/2022

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: lee n, buchanan i, zuckermann s, boddapati v, mathew j, geiselmann m, park p, leung e, buchholz a, kha a, mullin j, pollina j, jazini e, haines c, schuler t, good c, lombardi j, lehman r.What is the comparison in robot time per screw, radiation exposure, robot abandonment, screw accuracy, and clinical outcomes between percutaneous and open robot-assisted short lumbar fusion? a multicenter, propensity-matched analysis of 310 patients.Spine an international journal for the study of the spine.2022.47(1):42-48.Doi: 10.10 97/brs.0000000000004132.If information is provided in the future, a supplemental report will be issued.

Event Description

Abstract: to compare the robot time/screw, radiation exposure, robot abandonment, screw accuracy, and 90-day outcomes between robot-assisted percutaneous and robot-assisted open approach for short lumbar fusion (1-and 2-level).There is conflicting literature on the superiority of robot assisted minimally invasive spine surgery to open techniques.A large, multicenter study is needed to further elucidate the outcomes and complications between these two approaches.We included adult patients (=18 years old) who underwent robot-assisted short lumbar fusion surgery from 2015-2019 at four independent institutions.A propensity score matching (psm) algorithm was employed to control for the potential selection bias between percutaneous and open surgery.The minimum follow-up was 90 days after the index surgery.After psm, 310 patients remained.The mean (standard deviation) charlson comorbidity index was 1.6 (1.5) and 53% of patients were female.The most common diagnoses included high grade spondylolisthesis (grade >2) (48%), degenerative disc disease (22%), and spinal stenosis (25%), and the mean number of instrumented levels was 1.5 (0.5).The operative time was longer in the open (198 minutes) vs.The percutaneous group (167 minutes, p-value=0.007).However, the robot time/screw was similar between cohorts (pvalue>0.05).The fluoroscopy time/screw for percutaneous (14.4 seconds) was longer than the open group (10.1 seconds, p-value=0.021).The rates for screw exchange and robot abandonment, were similar between groups (p-value>0.05).The estimated blood loss (open: 146ml vs.Percutaneous: 61.3ml, p-value<0.001) and transfusion rate (open: 3.9% vs.Percutaneous: 0%, p-value=0.013) were greater for the open group.The 90-day complication rate and mean length of stay were not different between cohorts (p-value>0.05).Percutaneous robot-assisted spine surgery may increase radiation exposure, but can achieve a shorter operative time and lower risk for intraoperative blood loss for short lumbar fusion.Percutaneous approaches do not appear to have an advantage for other short term postoperative outcomes.Future multicenter studies on longer fusion surgeries and the inclusion of patient-reported outcomes are needed.Reported events: after use of the guidance system to place screws during spinal surgery, nine patients experienced wound complications within 90 days after surgery.A revision was required.During use of the guidance system to place screws for spinal surgery, 11 malpositioned screws had to be repositioned during the procedure.

• 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: 13665204
• MDR Text Key: 291307068
• Report Number: 3005075696-2022-00024
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• 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
• Date Manufacturer Received: 02/04/2022
• 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): Required Intervention