BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAZOR X SYSTEM

    MDR report key: 23647826 · Received November 25, 2025

    Report

    Report Number
    3005075696-2025-00388
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    September 26, 2025
    Report Date
    November 25, 2025
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    PMA / PMN Number
    K182077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A5) PATIENT INFORMATION WAS INCLUDED IN THE ARTICLE. A2) THIS VALUE REPRESENTS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A3) THIS VALUE REPRESENTS THE MAJORITY SEX OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A4) THE WEIGHT OF THE PATIENTS WAS NOT PROVIDED. A1) PATIENT IDENTIFIER(S) WAS NOT INCLUDED IN THE ARTICLE. B3) PLEASE NOTE THAT THIS DATE IS BASED OFF THE PUBLICATION DATE OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THIS PUBLISHED LITERATURE. B5) INCLUDED THE ARTICLE CITATION. D4) THE SYSTEM SERIAL NUMBER WAS NOT PROVIDED IN THE JOURNAL ARTICLE. H3, H6) NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H4) DEVICE MANUFACTURING DATE WAS UNAVAILABLE. H6) MULTIPLE PATIENT CODES WERE APPLIED. SEE BELOW FOR CLARIFICATION: E0106 - CEREBROSPINAL FLUID (CSF) LEAK E2115 - POST OPERATIVE WOUND INFECTION E2401 - "MEDICALLY ADVERSE EVENTS" E0505 - HEMATOMA THE ARTICLE WAS NOT PROVIDED AS DIGITAL SHARING OF THE ARTICLE WOULD BE IN VIOLATION OF COPYRIGHT PERMISSION. 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

    CITATION: SEIF, HASSAN, ET AL. ¿A RETROSPECTIVE COHORT STUDY COMPARING ROBOT-ASSISTED AND CONVENTIONAL FLUOROSCOPY-GUIDED PEDICLE SCREW PLACEMENT.¿ JOURNAL OF CLINICAL MEDICINE, VOL. 14, NO. 19, 26 SEPT. 2025, PP. 1¿14, HTTPS://DOI.ORG/10.3390/JCM14196831. BACKGROUND/OBJECTIVES: PEDICLE SCREW PLACEMENT IS CRUCIAL FOR RESTORING STABILITY. EMERGING ROBOT-ASSISTED TECHNOLOGIES MAY OFFER ENHANCED PRECISION AND REDUCED RADIATION EXPOSURE. THIS STUDY AIMED TO COMPARE THE ACCURACY AND CLINICAL OUTCOMES OF ROBOT-ASSISTED VERSUS CONVENTIONAL FLUOROSCOPY-GUIDED PEDICLE SCREW PLACEMENTS. METHODS: THIS RETROSPECTIVE COHORT STUDY INCLUDED 218 PATIENTS UNDERGOING PEDICLE SCREW PLACEMENT AT A SINGLE SPINE CENTER BETWEEN 2019 AND 2023. OF THESE, 105 PATIENTS UNDERWENT ROBOT-ASSISTED SURGERY USING THE MAZOR X¿ STEALTH EDITION (MEDTRONIC, MINNEAPOLIS, MN, USA), AND 113 UNDERWENT CONVENTIONAL FLUOROSCOPY-GUIDED SURGERY. THE PRIMARY OUTCOME WAS SCREW PLACEMENT ACCURACY (GRADE 0 = OPTIMAL, GRADES 1¿3 = SUBOPTIMAL, ACCORDING TO THE GERTZBEIN¿ROBBINS CLASSIFICATION). SECONDARY OUTCOMES INCLUDED ESTIMATED BLOOD LOSS (EBL), RADIATION EXPOSURE, LENGTH OF HOSPITAL STAY (LOS), CLINICAL OUTCOME ACCORDING TO THE MACNAB CLASSIFICATION, POSTOPERATIVE PAIN, AND ADVERSE EVENTS. RESULTS: ROBOT-ASSISTED SURGERY DEMONSTRATED SIGNIFICANTLY HIGHER ACCURACY IN SCREW PLACEMENT, WITH 93.33% ACHIEVING GRADE 0 ACCURACY VERSUS 78.76% IN THE CONVENTIONAL GROUP (P = 0.002). THIS CORRESPONDED TO AN ODDS RATIO (OR) OF 3.78 (95% CI: 1.55¿9.19, P = 0.003). THE NUMBER NEEDED TO TREAT (NNT) TO ACHIEVE ONE ADDITIONAL OPTIMAL SCREW PLACEMENT WAS 6.9. ROBOT-ASSISTED SURGERY DEMONSTRATED SIGNIFICANTLY HIGHER ACCURACY IN SCREW PLACEMENT. MOREOVER, ROBOT-ASSISTED PROCEDURES WERE ASSOCIATED WITH REDUCED ESTIMATED BLOOD LOSS (EBL), SHORTER LENGTH OF STAY (LOS), AND LOWER RADIATION EXPOSURE TIMES; PATIENT-REPORTED OUTCOMES (VAS AND MACNAB) WERE ALSO IMPROVED (OR = 3.34, 95% CI: 1.89¿5.91). DURATION OF SURGERY, ADVERSE EVENTS, AND REVISION RATES WERE COMPARABLE BETWEEN THE TWO GROUPS. CONCLUSIONS: THIS STUDY SUPPORTS THE CLINICAL BENEFITS OF ROBOT-ASSISTED PEDICLE SCREW PLACEMENT, PARTICULARLY IN ACHIEVING HIGHER ACCURACY AND REDUCING EBL AND LOS. FUTURE RESEARCH SHOULD EXPLORE LONG-TERM OUTCOMES, COST-EFFECTIVENESS, AND THE GENERALIZABILITY OF THESE RESULTS TO A BROADER PATIENT POPULATION. REPORTABLE EVENTS: 7 PATIENTS EXPERIENCED SUBOPTIMAL SCREW PLACEMENT. 2 PATIENTS EXPERIENCED SCREW MISPLACEMENT. 7 PATIENTS UNDERWENT REVISION SURGERY. 2 PATIENTS EXPERIENCED SURGICAL SITE INFECTIONS. 2 PATIENTS EXPERIENCED CEREBROSPINAL FLUID (CSF) LEAK. 2 PATIENTS EXPERIENCED MEDICALLY ADVERSE EVENTS. 1 PATIENT EXPERIENCED A HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1920333 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other