• 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 Imprecision (1307)
Patient Problems Cerebrospinal Fluid Leakage (1772); Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Muscle Weakness (1967); Neuropathy (1983); Tissue Breakdown (2681); Insufficient Information (4580)
Event Date 02/01/2022
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: yu c, carreon l, glassman s, brown m, daniels c, polly d, gum j. Propensity-matched comparison of 90-day complications in robotic-as sisted versus non-robotic assisted lumbar fusion. Spine. 2022. Volume 47, number 3, pp 195¿200. Doi: 10. 1097/brs. 0000000000004288 if information is provided in the future, a supplemental report will be issued.
 
Event Description
Abstract: to compare 90-day complication rates between robotic-assisted and non-robotic-assisted lumbar spinal fusions in propensity-matched c ohorts. A recent administrative database (pearldiver) study reported increased 30-day complications with the utilization of robotic-assisted enabling technology. Of 146 robotic-assisted cases that met inclusion criteria, 114 were successfully propensity matched to 114 patients from 214 cases who had 1 to 3 level lumbar fusion without robotic assistance based on age, sex, body mass index, smoking status, american society of anesthesiologist grade, number of surgical levels, primary versus revision, and surgical approach (posterior-only or anterior-posterior). We excluded tumor, trauma, infection, or deformity cases. Outcomes included surgical and medical (major/minor) complications at intraoperative, immediately postoperative, 30- and 90-day postoperative intervals, including reoperations, and readmissions within 90 days. All cause intraoperative complication rates were similar between non-robotic-assisted (5. 3%) and robotic-assisted groups (10. 5%, p¼0. 366). Immediate postoperative medical complication rate was also similar between non-robotic-assisted (6. 1%) and robotic-assisted groups (1. 8%, p¼0. 089). Thirty-day complication rates, 90-day complication rates, reoperation rates, and readmission rates showed no difference between nonrobotic-assisted and robotic-assisted groups. There was no difference between return to or for infection between the cohorts (non-robotic-assisted: 6 [5%] vs. Robotic-assisted: 1 [0. 8%], p¼0. 119). There was however improved length of stay (los) in the robotic-assisted group compared with non-robotic assisted group (2. 5 vs. 3. 17 days, p¼0. 018). In propensity-matched cohorts, patients undergoing 1- to 3-level robotic-assisted posterior lumbar fusion for degenerative conditions did not have increased 90-day complication rate, and had a shorter length of stay compared with non robotic-assisted patients. There findings differ from a prior administrative database study as the robotic-assisted group in the current study had 0% return to or for malpositioned screws and 0. 8% return to or for infection. Reported events: 1 - after undergoing 1to 3 level lumbar fusion surgery for degenerative conditions using the guidance system, one patient experienced a csf leak that required repair. 2 - after undergoing 1 to 3 level lumbar fusion surgery for degenerative conditions using the guidance system, five patients experienced le weakness and radiculopathy. 3 - after undergoing 1 to 3 level lumbar fusion surgery for degenerative conditions using the guidance system, one patient experienced pedicle fracture and rle radiculopathy. 4 - after undergoing 1 to 3 level lumbar fusion surgery for degenerative conditions using the guidance system, eight patients experienced wound dehiscence needing drainage. 5 - after undergoing 1 to 3 level lumbar fusion surgery for degenerative conditions using the guidance system, one patient experienced wound infection requiring. D. 6 - after undergoing 1 to 3 level lumbar fusion surgery for degenerative conditions using the guidance system, one patient experienced incision and drainage. 7 - while undergoing 1 to 3 level lumbar fusion surgery for degenerative conditions using the guidance system, 12 patients experienced complications including durotomy, hemorrhage and malpositioned hardware. No revisions were done due to malpositioned hardware.
 
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 Key13665341
MDR Text Key286599744
Report Number3005075696-2022-00026
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 03/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2022
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
Date Device Manufactured11/01/2017
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: 03/04/2022 Patient Sequence Number: 1
-
-