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

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.

• 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: 13665341
• MDR Text Key: 286599744
• Report Number: 3005075696-2022-00026
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109180465
• UDI-Public: 07290109180465
• 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

• 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
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 03/04/2022
• Date Device Manufactured: 11/01/2017
• 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