BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZOR X SYSTEM

    MDR report key: 21378402 · Received February 13, 2025

    Report

    Report Number
    3005075696-2025-00189
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    October 22, 2022
    Report Date
    February 13, 2025
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    PMA / PMN Number
    K182077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 WAS INCLUDED IN THE JOURNAL. A.2. THIS VALUE IS THE MEAN AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.4. THE PATIENT'S WEIGHT WAS NO PROVIDED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS PUBLISHED ONLINE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. B.5. INCLUDED THE ARTICLE CITATION D.4. THE SYSTEM SERIAL NUMBER WAS NOT PROVIDED IN THE JOURNAL ARTICLE. H.3. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H.4. DEVICE MANUFACTURING DATE WAS UNAVAILABLE. 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

    SHENG-YANG DU, JUN DAI, ZHEN-TAO ZHOU, BING-CHEN SHAN, FENG-XIAN JIANG, JING-YAN YANG, LEI CAO AND XIAO-ZHONG ZHOU. SIZE SELECTION AND PLACEMENT OF PEDICLE SCREWS USING ROBOT-ASSISTED VERSUS FLUOROSCOPY-GUIDED TECHNIQUES FOR THORACOLUMBAR FRACTURES: POSSIBLE IMPLICATIONS FOR THE SCREW LOOSENING RATE. BMC SURGERY. H TTPS://DOI.ORG/10.1186/S12893-022-01814-6 ABSTRACT: THERE HAS BEEN INCREASED DEVELOPMENT OF ROBOTIC TECHNOLOGIES FOR THE ACCURACY OF PERCUTANEOUS PEDICLE SCREW PLACEMENT. HOWEVER, IT REMAINS UNCLEAR WHETHER THE ROBOT REALLY OPTIMIZE THE SELECTION OF SCREW SIZES AND ENHANCE SCREW STABILITY. THE PURPOSE OF THIS STUDY IS TO COMPARE THE SIZES (DIAMETER AND LENGTH), PLACEMENT ACCURACY AND THE LOOSENING RATE OF PEDICLE SCREWS USING ROBOTIC ASSISTED VERSUS CONVENTIONAL FLUOROSCOPY APPROACHES FOR THORACOLUMBAR FRACTURES. METHODS: A RETROSPECTIVE COHORT STUDY WAS CONDUCTED TO EVALUATE 70 CONSECUTIVE PATIENTS [34 CASES OF ROBOTASSISTED PERCUTANEOUS PEDICLE SCREW FIXATION (RAF) AND 36 OF CONVENTIONAL FLUOROSCOPY-GUIDED PERCUTANEOUS PEDICLE SCREW FIXATION (FGF)]. DEMOGRAPHICS, CLINICAL CHARACTERISTICS, AND RADIOLOGICAL FEATURES WERE RECORDED. PEDICLE SCREW LENGTH, DIAMETER, AND PEDICLE SCREW PLACEMENT ACCURACY WERE ASSESSED. THE PATIENTS¿ SAGITTAL KYPHOSIS COBB ANGLES (KCA), ANTERIOR VERTEBRAL HEIGHT RATIOS (VHA), AND SCREW LOOSENING RATE WERE EVALUATED BY RADIOGRAPHIC DATA 1 YEAR AFTER SURGERY. RESULTS: THERE WAS NO SIGNIFICANT DIFFERENCE IN THE MEAN COMPUTED TOMOGRAPHY (CT) HOUNSFIELD UNIT (HU) VALUES, OPERATION DURATION, OR LENGTH OF HOSPITAL STAY BETWEEN THE GROUPS. COMPARED WITH THE FGF GROUP, THE RAF GROUP HAD A LOWER FLUOROSCOPY FREQUENCY [14 (12¿18) VS. 21 (16¿25), P 0.001] AND A HIGHER ¿GRADE A + B¿ PEDICLE SCREW PLACEMENT RATE (96.5% VS. 89.4%, P 0.05). THE MEAN SCREW DIAMETER WAS 6.04 ± 0.55 MM IN THE RAF GROUP AND 5.78 ± 0.50 MM IN THE FGF GROUP (P 0.001). THE MEAN SCREW LENGTH WAS 50.45 ± 4.37 MM IN THE RAF GROUP AND 48.63 ± 3.86 MM IN THE FGF GROUP (P 0.001). THE CORRECTION LOSS OF THE KCA AND VHR OF THE RAF GROUP WAS LESS THAN THAT OF THE FGT GROUP AT THE 1-YEAR FOLLOW-UP [(3.8 ± 1.8° VS. 4.9 ± 4.2°) AND (5.5 ± 4.9% VS. 6.4 ± 5.7%)], AND SCREW LOOSENING OCCURRED IN 2 OUT OF 34 PATIENTS (5.9%) IN THE RAF GROUP, AND 6 OUT OF 36 PATIENTS (16.7%) IN THE FGF GROUP, BUT THERE WERE NO SIGNIFICANT DIFFERENCES (P > 0.05). CONCLUSION: COMPARED WITH THE FLUOROSCOPY-GUIDED TECHNIQUE, ROBOTIC-ASSISTED SPINE SURGERY DECREASED RADIATION EXPOSURE AND OPTIMIZES SCREW TRAJECTORIES AND DIMENSIONS INTRAOPERATIVELY. ALTHOUGH NOT STATISTICALLY SIGNIFICANT, THE LOOSENING RATE OF THE RAF GROUP WAS LOWER THAT OF THAN THE FGT GROUP. REPORTED EVENTS: ELEVEN SCREWS WERE PLACED WITH THE GUIDANCE SYSTEM RESULTED IN A CORTICAL BREACH OF 2MM. FIVE SCREWS WERE PLACED WITH THE G UIDANCE SYSTEM RESULTED IN A CORTICAL BREACH OF > OR EQUAL TO 2MM AND 4 MM. TWO SCREWS WERE PLACED WITH THE GUIDANCE SYSTEM RESULTED IN A CORTICAL BREACH OF > OR EQUAL TO 4MM. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881761 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male