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Model Number TPL0059
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Cerebrospinal Fluid Leakage (1772); Nerve Damage (1979); Unspecified Nervous System Problem (4426); Insufficient Information (4580)
Event Date 05/12/2021
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: lee n, zuckerman s, buchanan i, boddapati v, mathew j, leung e, park p, pham m, bucholz a, khan a, pollina j, mullin j, jazini e, haines c, schuler t, good c, lombardi j, lehman r. Is there a difference between navigated and non-navigated robot cohorts in robot-assisted spine surgery? a multicenter, propensity-matched analysis of 2,800 screws and 372 patients. The spine journal. 2021. 1-9. Htt ps://doi. Org/10. 1016/j. Spinee. 2021. 05. 015. If information is provided in the future, a supplemental report will be issued.
Event Description
Abstract: robot-assisted spine surgery continues to rapidly develop as evidenced by the growing literature in recent years. In addition to demonstrating excellent pedicle screw accuracy, early studies have explored the impact of robot-assisted spine surgery on reducing radiation time, length of hospital stay, operative time, and perioperative complications in comparison to conventional freehand technique. Recently, the mazor x stealth edition was introduced in 2018. This robotic system integrates medtronic¿s stealth navigation technology into the mazor x platform, which was introduced in 2016. It is unclear what the impact of these advancements have made on clinical outcomes. To compare the outcomes and complications between the most recent iterations of the mazor robot systems: mazor x and mazor x stealth edition. Among four different institutions, we included adult (
18 years old) patients who underwent robot-assisted spine surgery with either the mazor x (non-navigated robot) or stealth (navigated robot) platforms. Primary outcomes included robot time per screw, fluoroscopic radiation time, screw accuracy, robot abandonment, and clinical outcomes with a minimum 90 day follow up. A one-to-one propensity-score matching algorithm based on perioperative factors (e. G. Demographics, comorbidities, primary diagnosis, open vs. Percutaneous instrumentation, prior spine surgery, instrumented levels, pelvic fixation, interbody fusion, number of planned robot screws) was employed to control for the potential selection bias between the two robotic systems. Chi-square/ fisher exact test and t-test/anova were used for categorical and continuous variables, respectively. From a total of 646 patients, a total of 372 adult patients were included in this study (x: 186, stealth: 186) after propensity score matching. The mean number of instrumented levels was 4. 3. The mean number of planned robot screws was 7. 8. Similar total operative time and robot time per screw occurred between cohorts (p>0. 05). However, stealth achieved significantly shorter fluoroscopic radiation time per screw (stealth: 7. 2 seconds vs. X: 10. 4 seconds, p<(><<)>. 001) than x. The screw accuracy for both robots was excellent (stealth: 99. 6% vs. X: 99. 1%, p
0. 120). In addition, stealth achieved a significantly lower robot abandonment rate (stealth: 0% vs. X: 2. 2%, p
0. 044). Furthermore, a lower blood transfusion rate was observed for stealth than x (stealth: 4. 3% vs. X: 10. 8%, p
0. 018). Non-robot related complications such as dura tear, motor/sensory deficits, return to the operating room during same admission, and length of stay was similar between robots (p>0. 05). The 90-day complication rates were low and similar between robot cohorts (stealth: 5. 4% vs. X: 3. 8%, p
0. 456). In this multicenter study, both robot systems achieved excellent screw accuracy and low robot time per screw. However, using stealth led to significantly less fluoroscopic radiation time, lower robot abandonment rates, and reduced blood transfusion rates than mazor x. Other factors including length of stay, and 90-day complications were similar. Reported event: after use of the guidance system during spinal procedures, there were seven occurrences of intraoperative dural tears, two occurrences of intraoperative loss of motor/sensory function, and two occurrences of a revision procedure being required. During the 90 day follow up period after the use of the guidance system during spinal procedures, there were four occurrences of wound complications, one occurrence of neurologic deficit, one occurrence of persistent symptoms requiring decompression, and one occurrence of an unknown symptom that required reoperation.
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Manufacturer (Section D)
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
IS 3079567
Manufacturer (Section G)
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
IS 3079567
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key12269139
MDR Text Key265763918
Report Number3005075696-2021-00089
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTPL0059
Device Catalogue NumberTPL0059
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/03/2021 Patient Sequence Number: 1