BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZOR X SYSTEM

    MDR report key: 23828315 · Received December 17, 2025

    Report

    Report Number
    3005075696-2025-00403
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 10, 2025
    Report Date
    December 17, 2025
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    UDI-DI
    07290115751376
    PMA / PMN Number
    K182077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 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.6. MULTIPLE DEVICE CODES WERE APPLIED. BELOW CLARIFIES WHAT EACH IS ASSOCIATED WITH. A0908 - INACCURACY A23 - REGISTRATION ISSUE 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

    KASHTIARA, A., BELDÉ, S., THIJS, D., DE BONDT, T., VAN GOETHEM, J.,VAN DE KELFT, E. (2025). FEASIBILITY OF SYNTHETIC CT IMAGES FOR ROBOTIC PEDICLE SCREW PLANNING AND NAVIGATION. EUROPEAN SPINE JOURNAL. HTTPS://DOI.ORG/10.1007/S00586-025-09568-4 SUMMARY PURPOSE: SPINAL ROBOTIC GUIDANCE PLATFORMS, WHICH RELY ON COMPUTED TOMOGRAPHY (CT) OR CONE BEAM CT (CBCT)-BASED NAVIGATION, ENABLE PRECISE PREOPERATIVE PLANNING AND INTRAOPERATIVE PLACEMENT OF PEDICLE SCREWS. HOWEVER, THEY ALSO RESULT IN SIGNIFICANT RADIATION EXPOSURE TO BOTH PATIENTS AND CLINICAL STAFF. A RECENTLY FDA- AND CE-APPROVED HIGH-RESOLUTION SYNTHETIC COMPUTED TOMOGRAPHY (SCT) TECHNOLOGY ALLOWS THE GENERATION OF CT-EQUIVALENT IMAGES FROM MAGNETIC RESONANCE IMAGING (MRI) DATA, POTENTIALLY REDUCING RADIATION EXPOSURE. AIM: TO ASSESS THE FEASIBILITY OF USING MRI-DERIVED SCT IMAGES FOR PEDICLE SCREW PLANNING AND ROBOTIC NAVIGATION, AND TO COMPARE PATIENT RADIATION DOSES BETWEEN STANDARD CT-BASED AND SCT-BASED WORKFLOWS. METHODS: TWELVE PATIENTS SCHEDULED FOR THORACOLUMBAR PEDICLE SCREW FIXATION UNDERWENT 3T MRI WITH ADDITIONAL T1-WEIGHTED 3D DUAL-ECHO GRADIENT-ECHO (GRE) SEQUENCES. THESE GRE DATASETS WERE CONVERTED INTO SCT IMAGES USING BONEMRI® V1.8 (MRIGUIDANCE B.V.) AND IMPORTED INTO THE MAZOR¿ ROBOTIC GUIDANCE SYSTEM FOR PREOPERATIVE PLANNING, SCT-TO-FLUOROSCOPY FUSION, AND INTRAOPERATIVE NAVIGATION. RADIATION DOSES WERE ESTIMATED USING MONTE CARLO¿BASED NCICT AND NCIRF DOSIMETRY MODELS, AND COMPARED TO THOSE FROM CONVENTIONAL CT-BASED WORKFLOWS. RESULTS: SCT IMAGES WERE VISUALLY COMPARABLE TO CONVENTIONAL CT AND FULLY COMPATIBLE WITH THE ROBOTIC NAVIGATION PLATFORM FOR BOTH PLANNING AND EXECUTION. REPLACING CT WITH SCT REDUCED PATIENT RADIATION EXPOSURE BY 98%, WITH RESIDUAL DOSE PRIMARILY RESULTING FROM INTRAOPERATIVE FLUOROSCOPY USED FOR IMAGE FUSION AND VERIFICATION. CONCLUSION: MRI-DERIVED SCT OFFERS A RADIATION-FREE ALTERNATIVE TO CONVENTIONAL CT FOR SPINAL ROBOTIC GUIDANCE, ENABLING PEDICLE SCREW PLANNING AND NAVIGATION WHILE ELIMINATING CT-ASSOCIATED RADIATION EXPOSURE. REPORTED EVENT: TWELVE PATIENTS UNDERWENT A THORACOLUMBAR PEDICLE SCREW FIXATION WITH SCT. DURING A POST-OPERATIVE FOLLOW UP ONE L3 SCREW WAS REVISED DUE TO A MEDIAL BREACH. THIS BREACH WAS CONSIDERED A GRADE II ACCORDING TO THE HEARY CLASSIFICATION. ADDITIONALLY, IT WAS NOTED THAT FOR AN S1 SCREW PLACEMENT, IT WAS NOT FEASIBLE TO PERFORM WITH THE GUIDANCE SYSTEM DUE TO THE STEEP ANGLE AND POTENTIAL COLLISION WITH THE L5 SCREW HEADS. THE S1 AND ILIUM SCREWS WERE PLACED USING FLUOROSCOPY. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT IN A CASE WITH A 70 YEAR OLD FEMALE THE L5 SCREW TR AJECTORY PLANNED WAS NOT POSSIBLE DUE TO THE PRESENCE OF A DISC PROSTHESIS AT L5/S1. THIS DISC CAUSED A LARGER THAN USUAL METAL ARTIFACT, AND THUS THE REGISTRATION FAILED AT THAT LEVEL. ADDITIONALLY IN A CASE INVOLVING A 71 YEAR OLD FEMALE THE SCREW TRAJECTORIES FROM L2 TO S1 WERE EXCLUDED DUE TO PEDICLE SCREWS ALREADY BEING PRESENT. THESE SCREWS CAUSE METAL ARTIFACTS, AND THUS REGISTRATION FAILED AS WELL. FOR THE CASE INVOLVING THE MEDIAL BREACH, THE SURGEON FELT THERE WAS NO CLEAR EXPLANATION AS TO WHY IT OCCURRED. THESE ISSUES RESULTED IN A DELAY OF LESS THAN ONE HOUR. ALL PLACEMENTS THAT WERE NOT POSSIBLE WITH THE GUIDANCE SYSTEM WERE PLACED FREEHAND UNDER FLUOROSCOPY. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039145 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059 07290115751376

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female