• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAZOR ROBOTICS LTD MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMAZOR X SYSTEM
Type of DeviceORTHOPEDIC 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 Key13658409
MDR Text Key286513536
Report Number3005075696-2022-00021
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180307
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 03/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTPL0059
Device Catalogue NumberTPL0059
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2022
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: 03/03/2022 Patient Sequence Number: 1
-
-