BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAZOR X SYSTEM

    MDR report key: 21752062 · Received April 2, 2025

    Report

    Report Number
    3005075696-2025-00240
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    February 1, 2020
    Report Date
    April 9, 2025
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2) SEE ATTACHMENTS. 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.

    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 MONTH AND YEAR THE STUDY BEGAN AS NOTED IN THE LITERATURE 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. CITATION: WORLD NEUROSURG. (2025) 194:123478. HTTPS://DOI.ORG/10.1016/J.WNEU.2024.11.061 H4) 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

    DE BIASE, G., GRUENBAUM, B. F., BOJAXHI, E., PATTERSON, J. S., SABETTA, K., QUINONES-HINOJOSA, A., ABODE-IYAMAH, K. (2025). AWAKE MINIMALLY INVASIVE SURGERY TRANSFORAMINAL LUMBAR INTERBODY FUSION UNDER SPINAL ANESTHESIA: SCREW PLACEMENT ACCURACY AND 1 YEAR FOLLOW-UP. WORLD NEUROSURGERY, 194(123478), 1¿7. HTTPS://DOI.ORG/10.1016/J.WNEU.2024.11.061 OBJECTIVE: WE ASSESSED THE ACCURACY OF PEDICLE SCREWS PLACED DURING AWAKE MINIMALLY INVASIVE SURGERY (MIS) TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) UNDER SPINAL ANESTHESIA AND ANALYZED OUTCOMES AT THE 1-YEAR FOLLOW-UP. METHODS: WE INCLUDED PATIENTS WHO UNDERWENT AWAKE MIS-TLIF UNDER SPINAL ANESTHESIA AT AN ACADEMIC CENTER FROM FEBRUARY 2020 TO FEBRUARY 2022. THE GERTZBEIN-ROBBINS CLASSIFICATION WAS USED FOR SCREW ACCURACY RATING. RESULTS: A TOTAL OF 100 PEDICLE SCREWS WERE INSERTED IN 24 PATIENTS, WITH THE MOST COMMON LEVEL BEING L4-5. MEDIAN AGE WAS 63.5 ±16.5 (INTERQUARTILE RANGE) YEARS, 42% MALE, MEDIAN BODY MASS INDEX 28 ± 6 KG/M2, AND MEDIAN AMERICAN SOCIETY OF ANESTHESIOLOGISTS CLASS WAS 2 ± 1. TWO PATIENTS UNDERWENT A 2-LEVEL FUSION, AND 22 PATIENTS UNDERWENT A 1-LEVEL FUSION. MEDIAN ESTIMATED BLOOD LOSS WAS 35 ± 25 ML, MEDIAN LENGTH OF STAY WAS 0 ± 1 DAY, WITH 54% OF PATIENTS GOING HOME ON THE DAY OF SURGERY, AND THE ONLY INTRAOPERATIVE COMPLICATION WAS 1 DUROTOMY. MEDIAN PROCEDURE TIME WAS 112 ± 23.5 MINUTES, AND MEDIAN OPERATING ROOM TIME (INCLUDING THE SPINAL BLOCK) WAS 159.5 ± 32.7 MINUTES; 67% OF THE SCREWS WERE PLACED WITH NAVIGATION, AND 33% WERE ROBOTIC-ASSISTED (MAZOR X); 99% OF THE SCREWS WERE GERTZBEIN ROBINS GRADE A, AND 1% GRADE E. AT THE 1 YEAR FOLLOW-UP, COMPUTED TOMOGRAPHY SHOWED NO EVIDENCE OF PSEUDARTHROSIS, AND ALL PATIENTS REPORTED IMPROVEMENT IN THEIR PRESENTING SYMPTOMS. CONCLUSIONS: OUR STUDY SHOWS A HIGH ACCURACY (99%) OF PEDICLE SCREW PLACEMENT IN PATIENTS UNDERGOING AWAKE MIS-TLIF UNDER SPINAL ANESTHESIA AND SIGNIFICANT IMPROVEMENT OF THEIR SYMPTOMS AT 1-YEAR FOLLOW-UP. REPORTED EVENTS: 33 PEDICLE SCREWS (8 PATIENTS) WERE PLACED WITH ROBOTIC ASSISTANCE AND 67 (16 PATIENTS) WERE PLACED WITH NAVIGATION FOR MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS-TLIF). 1% OF THE SCREWS PLACED WERE GRADED AS GRADE E, INDICATING OVER 6-MM OF PEDICLE BREACH. A SINGULAR CASE OF DUROTOMY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687037 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other