BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAZOR X SYSTEM

    MDR report key: 23866669 · Received December 22, 2025

    Report

    Report Number
    3005075696-2025-00415
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    September 5, 2025
    Report Date
    December 22, 2025
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    PMA / PMN Number
    K182077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 NOT PROVIDED. 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 D.4. THE SYSTEM SERIAL NUMBER WAS NOT PROVIDED IN THE JOURNAL ARTICLE. E.1. STREET 1 - NO. 49, HUAYUAN NORTH ROAD, HAIDIAN DISTRICT H.3. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H.4. DEVICE MANUFACTURING DATE WAS UNAVAILABLE. H.6. MULTIPLE PATIENT CODES WERE APPLIED. BELOW LISTED WHAT EACH CORRELATES TO. E0106 - CSF E0123 - LEFT L5 NERVE ROOT INJURY E0144 -DURAL INJURY E2330 - LEG PAIN E2401 - WORSENING ODI/JOA SCORE 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

    IAO, C., GUO, X., QIU, W., QI, Q., GUO, Z., SUN, C., ZHONG, W., & LI, W. (2025). RETROSPECTIVE ANALYSIS OF CLINICAL MANAGEMENT STRATEGIES FOR CAGE RETROPULSION FOLLOWING POSTERIOR LUMBAR INTERBODY FUSION. ORTHOPAEDIC SURGERY, 17(11), 3133¿3141. HTTPS://DOI.ORG/10.1111/OS.70174 SUMMARY OBJECTIVES: CAGE RETROPULSION (CR) IS A COMMON COMPLICATION FOLLOWING POSTERIOR LUMBAR INTERBODY FUSION (PLIF). SYMPTOMATIC PATIENTS WITH CR OFTEN REQUIRE REVISION SURGERY. HOWEVER, THERE IS A LACK OF LITERATURE SUPPORTING THE EFFECTIVENESS OF CONSERVATIVE TREATMENT FOR CR. THIS STUDY COMPARES CLINICAL AND RADIOGRAPHIC OUTCOMES BETWEEN CONSERVATIVE TREATMENT AND REVISION SURGERY IN PATIENTS WITH CR AFTER PLIF. METHODS: A TOTAL OF 55 PATIENTS WITH CR AFTER PLIF TREATED AT OUR INSTITUTION BETWEEN 2016 AND 2023 WERE RETROSPECTIVELY REVIEWED; P OSTOPERATIVE RADIOGRAPHIC DATA OF FOLLOW-UP WERE USED TO DIAGNOSE CR. CLINICAL OUTCOMES WERE ASSESSED BEFORE THERAPY AND AT THE FINAL FOLLOW-UP USING THE VISUAL ANALOG SCALE (VAS) FOR LOWER BACK PAIN AND LEG PAIN, OSWESTRY DISABILITY INDEX (ODI) SCORES, AND JAPANESE ORTHOPEDIC ASSOCIATION 29 (JOA-29) SCORES. THE TREATMENT EFFECTIVENESS WAS EVALUATED BASED ON WHETHER THE SCORE CHANGE REACHED THE MINIMALLY CLINICALLY IMPORTANT DIFFERENCE (MCID). RADIOGRAPHIC INDICATORS INCLUDED THE FUSION RATES, THE EXTENT OF CR INTO THE SPINAL CANAL, AND THE TOTAL DISPLACEMENT DISTANCE. CONTINUOUS VARIABLES WERE COMPARED USING INDEPENDENT SAMPLES T-TESTS OR MANN¿WHITNEY U TESTS, WHILE CATEGORICAL VARIABLES WERE ANALYZED USING CHI-SQUARE OR FISHER'S EXACT TESTS, AS APPROPRIATE. A P-VALUE <(><<)>0.05 WAS CONSIDERED STATISTICALLY SIGNIFICANT. RESULTS: THE FUSION RATES AT THE FINAL FOLLOW-UP FOR THE CONSERVATIVE TREATMENT GROUP AND THE REVISION SURGERY GROUP WERE 87.5% AND 84.6%, RESPECTIVELY. THERE WERE NO SIGNIFICANT DIFFERENCES IN FINAL FOLLOW-UP FUSION RATES, LOWER BACK PAIN VAS SCORES, LEG PAIN VAS SCORES, JOA SCORES, OR ODI SCORES BETWEEN THE TWO GROUPS (ALL P>0.05). ADDITIONALLY, THERE WAS NO DIFFERENCE IN THE PROPORTION OF PATIENTS WHOSE LOWER BACK PAIN VAS, ODI, AND JOA SCORES ACHIEVED MCID BETWEEN GROUPS (ALL P>0.05). HOWEVER, IN THE REVISION SURGERY GROUP, THE PROPORTION OF PATIENTS WHOSE LEG VAS SCORES REACHED MCID WAS SIGNIFICANTLY HIGHER THAN IN THE CONSERVATIVE GROUP (P=0.001). IN THE REVISION SURGERY SUBGROUP ANALYSIS, PATIENTS WHO DID NOT ACHIEVE LEG VAS MCID DEMONSTRATED SIGNIFICANTLY MORE SEVERE CAGE RETROPULSION DISTANCE COMPARED TO MCID ACHIEVERS (P=0.03). CONCLUSIONS: CONSERVATIVE TREATMENT YIELDS SATISFACTORY OUTCOMES IN MILD, SYMPTOMATIC CR PATIENTS, PARTICULARLY FOR LOW BACK PAIN. FOR PATIENTS WITH A CR DISTANCE LESS THAN 8.8MM, CONSERVATIVE TREATMENT AND REVISION SURGERY SHOWED COMPARABLE OUTCOMES, WHEREAS WHEN THE CR DISTANCE IS =8.8MM, REVISION SURGERY WAS RECOMMENDED TO IMPROVE CLINICAL RESULTS. BOTH CONSERVATIVE TREATMENT AND REVISION SURGERY CAN YIELD FAVORABLE OUTCOMES WHEN APPROPRIATELY INDICATED. REPORTED EVENTS: 39 PATIENTS UNDERWENT REVISION SPINAL SURGERY TO ADDRESS CAGE RETROPULSION. TWO OF THOSE PATIENTS HAD S2AI SCREWS FIXATED WITH A GUI DANCE SYSTEM. IT WAS NOTED THAT FIVE PATIENTS HAD A SMALL CEREBROSPINAL FLUID LEAK, ONE PATIENT HAD AN INJURY TO THE LEFT L5 NERVE ROOT, ONE PATIENT HAD NO IMPROVEMENT IN LEG PAIN, ONE PATIENT EXPERIENCED WORSENING LEG PAIN POSTOPERATIVELY, ONE PATIENT SHOWED A WO RSENING IN ODI SCORE, AND ONE PATIENT HAD A WORSENING IN JOA SCORE. IN SUMMARY, FIVE PATIENTS EXPERIENCED INTRAOPERATIVE COMPLICATIONS INVOLVING DURAL OR NERVE INJURIES, AND FOUR PATIENTS EXPERIENCED WORSENING OR NO IMPROVEMENT IN LEG PAIN AFTER THE PROCEDURE. THE PATIENTS WITH LEG PAIN ISSUES SHOWED SOME SYMPTOM IMPROVEMENT WITHIN THREE MONTHS WITH CONSERVATIVE SYMPTOMATIC TREATMENT, AND NO FURTHER SURGERY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746272 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention| O