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); Hematoma (1884); Neuropathy (1983); Seroma (2069); Post Operative Wound Infection (2446)

Event Date 11/26/2021

Event Type  Injury  

Event Description

Abstract: robotics is a major area for research and development in spine surgery.The high accuracy of robot-assisted placement of thoracolumbar pedicle screws is documented in the literature.The authors present the largest case series to date evaluating 90-day complication, revision, and readmission rates for robot-assisted spine surgery using the current generation of robotic guidance systems.An analysis of a retrospective, multicenter database of open and minimally invasive thoracolumbar instrumented fusion surgeries using the mazor x or mazor x stealth edition robotic guidance systems was performed.Patients 18 years of age or older and undergoing primary or revision surgery for degenerative spinal conditions were included.Descriptive statistics were used to calculate rates of malpositioned screws requiring revision, as well as overall complication, revision, and readmission rates within 90 days.In total, 799 surgical cases (mazor x: 48.81%; mazor x stealth edition: 51.19%) were evaluated, involving robot-assisted placement of 4838 pedicle screws.The overall intraoperative complication rate was 3.13%.No intraoperative implant-related complications were encountered.Postoperatively, 129 patients suffered a total of 146 complications by 90 days, representing an incidence of 16.1%.The rate of an unrecognized malpositioned screw resulting in a new postoperative radiculopathy requiring revision surgery was 0.63% (5 cases).Medical and pain-related complications unrelated to hardware placement accounted for the bulk of postoperative complications within 90 days.The overall surgical revision rate at 90 days was 6.63% with 7 implant-related revisions, representing an implant-related revision rate of 0.88%.The 90-day readmission rate was 7.13% with 2 implant-related readmissions, representing an implant-related readmission rate of 0.25% of cases.The results of this multicenter case series and literature review suggest current-generation robotic guidance systems are associated with low rates of intraoperative and postoperative implant-related complications, revisions, and readmissions at 90 days.Future outcomes-based studies are necessary to evaluate complication, revision, and readmission rates compared to conventional surgery.Reported events: after use of the guidance system to place screws during a spinal procedure, two patients experienced malpositioned screws.Intraop o-arm imaging confirmed minor lateral and superolateral breaches.The surgeons determined the breaches were clinically insignificant; however, the patient's experience new postoperative radiculopathy.Revision procedures were done and the symptoms resolved.After use of the guidance system to place screws during a spinal procedure, one patient experienced malpositioned screws.Intraop radiography was not concerning.The patient experienced new radiculopathy upon waking up.Ct demonstrated a minor lateral breach.A revision procedure were done and the symptoms resolved.After use of the guidance system to place screws during an open spinal procedure, one patient experienced malpositioned screws.Despite use of electromyography and fluoroscopic verification of screw placement, the patient developed new radiculopathy after a day.Ct demonstrated an inferior breach.A revision procedure were done and the symptoms resolved.After use of the guidance system to place screws during an open spinal procedure, one patient experienced malpositioned screws.The pedicle was fractured causing new radicular pain.A revision procedure were done and the symptoms resolved.After use of the guidance system to place screws during a spinal procedure, 21 patients experienced surgical site infections.8 infections developed within 30 days of the surgery and 13 developed between 30 to 90 days after the surgery.A revision procedure was done in 14 patients to washout the wound.After use of the guidance system to place screws during a spinal procedure, 8 patients experienced 8 postoperative hematomas or seromas.A revision procedure was done for 7 patients for evacuations.After use of the guidance system to place screws during a spinal procedure, one patient experienced a pseudomeningocele treated with primary surgical dural repair and lumbar drain placement.After use of the guidance system to placed screws during a spinal procedure, 21 screws were identified as malpositioned at the time of surgery.The deviated screws were identified by intraop c-arm or o-arm imaging in conjunction with neuromonitoring if used.The screws were repositioned during the procedure with no vascular, neurological or other complications.

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: liounakos j, khan a, eliahu k, mao j, good c, pollina j, haines c, gum j, schuler t, jazini e, chua r, shafa e, buchholz a, pham m, poelstra a, wang m.Ninety-day complication, revision, and readmission rates for current-generation robot-assisted thoracolumbar spinal fusion surgery: results of a multicenter case series.Journal of neurosurgery.2021.1¿8.Doi: 10.3171/2021.8.Spine21330.If information is provided in the future, a supplemental report will be issued.

• 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: 13615961
• MDR Text Key: 288983238
• Report Number: 3005075696-2022-00016
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109183213
• UDI-Public: 07290109183213
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182077
• 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: 02/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2022
• 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
• Date Manufacturer Received: 02/03/2022
• Date Device Manufactured: 12/01/2018
• 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