BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZOR X SYSTEM

    MDR report key: 21276970 · Received January 30, 2025

    Report

    Report Number
    3005075696-2025-00112
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    June 23, 2022
    Report Date
    January 30, 2025
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    PMA / PMN Number
    K182077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. A.1-A.5) PATIENT INFORMATION IS UNAVAILABLE. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. B.5. INCLUDED THE ARTICLE CITATION H.3. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    YOSHIAKI TORII, JUN UENO, MASAHIRO IINUMA, ATSUHIRO YOSHIDA, HISATERU NIKI, TSUTOMU AKAZAWA. ACCURACY OF ROBOTIC-ASSISTED PEDICLE SCREW PLACEMENT COMPARING JUNIOR SURGEONS WITH EXPERT SURGEONS: CAN JUNIOR SURGEONS PLACE PEDICLE SCREWS AS ACCURATELY AS EXPERT SURGEONS? JOURNAL OF ORTHOPAEDIC SCIENCE. BACKGROUND: THE PURPOSE OF THIS STUDY WAS TO VERIFY WHETHER A SPINE ROBOTIC SYSTEM WAS USEFUL FOR JUNIOR SURGEONS. METHODS: TWENTY-SEVEN PATIENTS UNDERWENT POSTERIOR SPINAL FUSION WITH OPEN SURGERY USING A SPINE ROBOTIC SYSTEM (MAZOR X STEALTH EDITION, MEDTRONIC INC., DUBLIN, IRELAND) FROM APRIL TO AUGUST 2021. PEDICLE SCREW INSERTIONS WERE PERFORMED BY FIVE SURGEONS. THE SURGEON AND INSERTION TIME WERE RECORDED FOR EACH PEDICLE SCREW. TWO SURGEONS WHO ARE BOARD-CERTIFIED SPINE SURGEONS BY THE JAPANESE SOCIETY FOR SPINE SURGERY AND RELATED RESEARCH (JSSR) WERE DEFINED AS THE EXPERT SURGEON GROUP. THREE SURGEONS WHO WERE TRAINING TO ACQUIRE QUALIFICATIONS AS JSSR BOARD CERTIFIED SPINE SURGEONS WERE DEFINED AS THE JUNIOR SURGEON GROUP. IN POSTOPERATIVE CT IMAGES, THE DEVIATION OF 255 PEDICLE SCREWS WAS EVALUATED USING THE GERTZBEIN-ROBBINS (GR) GRADES. RESULTS: IN THE EXPERT SURGEON GROUP, THE GR GRADES WERE GRADE A FOR 79 SCREWS (90.8%), GRADE B FOR 6 (6.9%), GRADE C FOR 2 (2.3%), AND 0 (0%) FOR GRADES D AND E. I IN THE JUNIOR SURGEON GROUP, THE GR GRADES WERE GRADE A FOR 162 SCREWS (96.4%), GRADE B FOR 6 (3.6%), AND 0 (0%) FOR GRADES C, D, AND E. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE DEVIATION RATE BETWEEN SURGEON GROUPS (P ¼ 0.08). THE MEAN INSERTION TIMES WERE 174.5 ± 83.0 S IN THE EXPERT SURGEON GROUP AND 191.0 ± 111.0 S IN THE JUNIOR SURGEON GROUP. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE INSERTION TIME BETWEEN SURGEON GROUPS (P ¼ 0.22). CONCLUSIONS: THERE WERE NO SIGNIFICANT DIFFERENCES IN THE DEVIATION RATE AND THE INSERTION TIME OF ROBOTIC ASSISTED PEDICLE SCREW PLACEMENT BETWEEN EXPERT SURGEONS AND JUNIOR SURGEONS WHO WERE TRAINING TO ACQUIRE QUALIFICATIONS AS JSSR BOARD CERTIFIED SPINE SURGEONS. ROBOTIC-ASSISTED PEDICLE SCREW PLACEMENT CAN BE EFFECTIVELY EMPLOYED BY JUNIOR SURGEONS. REPORTED EVENTS: TWELVE PATIENTS HAD A DEVIATION OF LESS THAN 2 MM. TWO PATIENTS HAD A DEVIATION OF 2MM OR MORE BUT LESS THAN 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533205 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown