• 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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Nervous System Problem (4426); Unspecified Tissue Injury (4559)
Event Date 04/18/2021
Event Type  Injury  
Manufacturer Narrative
Date of event. 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, boddapati v, mathew j, marciano g, fields m, buchana i, zuckerman s, park p, leung e, lombardi j, lehman r. Does robot-assisted spine surgery for multi-level lumbar fusion achieve better patient-reported outcomes than free-hand techniques? interdisciplinary neurosurgery: advanced techniques and case management. 2021. 25. Doi. Org/10. 1016/j. Inat. 2021. 101214. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Abstract: to compare the patient-reported outcomes (pros) between patients undergoing multilevel lumbar fusion with robot-assisted vs. Freehand techniques. This was a single-institution cohort study of adult patients (
=
18 years old) undergoing robot-assisted spine surgery from 2016 to 2018 with minimum 2-year follow-up. A propensity-score matching (psm) algorithm accounted for several perioperative factors. Pros were measured using the oswestry disability index (odi). The minimum clinically important difference (mcid) between groups were assessed at each follow-up period (6-weeks/6-months/1-year/2-years). Chi-square/fisher exact test and t-test/anova were used for categorical and continuous variables, respectively. After psm, a total of 70 patients remained. The mean (standard deviation) charlson comorbidity index was 1. 4 (1. 0) and 57% of patients were female. The most common diagnoses included degenerative disc disease (37. 1%), degenerative scoliosis (27. 1%), and high grade spondylolisthesis (grade > 2) (19%), and the mean number of instrumented levels was 4. 6 (4. 4). Rates for intraoperative/postoperative complications, and any reoperation within 2 years after surgery were low and similar between groups. The baseline odi scores were similar between freehand (39. 1) and robot-assisted surgery (40. 5, p-value
=
0. 736). By two years, substantial improvements in both groups (mean odi-freehand: 4. 6, robot-assisted: 1. 5; mcid%-freehand: 77. 1%, robot assisted: 82. 9%) were achieved, but not significantly different (p-value > 0. 05). No differences were observed for the other follow-up periods. When comparing individual component scores, the robot-assisted group scored higher in ¿lifting,¿ ¿sitting,¿ and ¿standing;¿ however, the magnitudes of these differences were less than 1 point. Robot-assisted multi-level lumbar fusion can achieve excellent and similar patient-reported outcomes to conventional freehand techniques. Future studies should include large, prospective randomized controlled trials as well as the inclusion of other patient reported outcome measures. Reported events: after use of the guidance system during spinal procedures, one patient required a revision procedure due to a wound complication. After use of the guidance system during spinal procedures, 10 patients experienced intraoperative dural tears requiring repair. After use of the guidance system during spinal procedures, one patient experienced intraoperative motor/sensory deficit that returned to baseline function post operatively during the same inpatient stay.
 
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
MDR Report Key12706940
MDR Text Key283753984
Report Number3005075696-2021-00117
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K182077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Type of Report Initial
Report Date 10/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/27/2021 Patient Sequence Number: 1
-
-