BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAISSANCE SYSTEM

    MDR report key: 21679025 · Received March 24, 2025

    Report

    Report Number
    3005075696-2025-00234
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    February 25, 2025
    Report Date
    March 24, 2025
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    HAW
    PMA / PMN Number
    K152041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1-A.5) PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS AVAILABLE 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. H.6. MULTIPLE DEVICE CODES WERE APPLIED. BELOW CLARIFIES WHAT EACH IS ASSOCIATED WITH. A0908 - INACCURACY A23 - REGISTRATION ERROR 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

    PATEL, N. A., BROWN, N. J., HE, C., PATEL, S., PENNINGTON, Z., GENDREAU, J., SAHYOUNI, R., PHAM, M. H. (2025). CHARACTERIZING THE COMPLICATION PROFILE OF SPINAL ROBOTIC SYSTEMS: A MAUDE ANALYSIS OF DEVICE FAILURES AND ASSOCIATED COMPLICATIONS BY DEVICE MANUFACTURER AND BRAND NAME. JOURNAL OF CLINICAL NEUROSCIENCE, 135, 111149. HTTPS://DOI.ORG/10.1016/J.JOCN.2025.111149 INTRODUCTION: PEDICLE SCREW PLACEMENT IN SPINAL SURGERY HAS EVOLVED TO INCORPORATE INCREASED USE OF TECHNOLOGY FOR BOTH PREOPERATIVE PLANNING AND INTRAOPERATIVE GUIDANCE. IN RECENT YEARS, ROBOTIC GUIDANCE HAS BEEN USED TO INCREASE THE PRECISION, ACCURACY, AND OVERALL PATIENT SAFETY OF SPINAL COLUMN FIXATION VIA SCREW PLACEMENT. WITHIN THIS CONTEXT, THE PRESENT STUDY AIMS TO QUANTIFY AND CLASSIFY COMPLICATIONS OF SPINAL ROBOTIC DEVICES USING A NATIONALLY REPRESENTATIVE DATABASE. METHODS: THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) WAS QUERIED FOR ADVERSE EVENTS INVOLVING THE MOST WIDELY USED SPINAL ROBOTIC DEVICES FROM INCEPTION TO NOVEMBER 3RD, 2023. ENTRIES WERE TABULATED BY ASSIGNING CATEGORICAL VARIABLES BASED ON EVENT INFORMATION. RESULTS: THE QUERY YIELDED 339 UNIQUE ROBOTIC FAILURE EVENTS. THE MOST FREQUENT COMPLICATIONS IN ROBOTIC-ASSISTED SPINAL SURGERIES WERE IMPRECISION (73.6%), SOFTWARE ERRORS (13.7%), AND DAMAGED OR MISSING SCREWS (4.9%). MOST REPORTED EVENTS OCCURRED INTRAOPERATIVELY AFTER THE INITIAL INCISION (78.5%) [COMPARED TO PREOPERATIVELY OR POSTOPERATIVELY]. THE MAZOR X¿ SYSTEM WAS THE MOST REPRESENTED SPINAL ROBOTIC PLATFORM IN TERMS OF COMPLICATIONS, ACCOUNTING FOR 71.6% OF REPORTED ROBOTIC FAILURE EVENTS. MOST REPORTED ERRORS WERE RESOLVED INTRA-OPERATIVELY OR CONTINUED THROUGH THE EMPLOYMENT OF ALTERNATIVE IMAGING METHODS AND, OVERALL, HAD MINIMAL CLINICAL SIGNIFICANCE. WITH RESPECT TO ROBOT-ASSISTED PEDICLE SCREW PLACEMENT, MEDIAL BREACHES WERE 1.7X MORE COMMON THAN LATERAL BREACHES ACROSS ALL ROBOTIC SYSTEMS. FINALLY, REGARDING THE IMPACT OF DEVICE FAILURES ON PERIOPERATIVE TIMING, WE FOUND THAT 10.3% OF ADVERSE EVENTS RESULTED IN DELAYS GREATER THAN 1 H. CONCLUSION: ULTIMATELY, IMPRECISION AND UNRESPONSIVE SOFTWARE WERE FOUND TO BE TWO OF THE MOST FREQUENT COMPLICATIONS OF ROBOT-ASSISTED SPINE SURGERY. THOUGH MOST REPORTED ERRORS WERE CIRCUMVENTED INTRAOPERATIVELY THROUGH CONVENTIONAL, NON-ROBOTIC IMAGING/GUIDANCE METHODS, 10.3% OF ADVERSE EVENTS RESULTED IN PROCEDURAL DELAYS OF GREATER THAN 1 H. REPORTED EVENTS 12 PATIENTS UNDERWENT A SPINAL PROCEDURE. OF THESE PROCEDURES, IN TWO, THE ISSUES WERE IDENTIFIED IN THE OPERATING ROOM AFTER ANESTHESIA, AND 10 WERE IDENTIFIED AFTER THE INCISION WAS MADE. 4 OF THESE PROCEDURES WERE CONTINUED WITHOUT CORRECTION AFTER THE ISSUE OCCURRED, 2 AMELIORATED, 5 CONTINUED WITH FLUORO, AND FOR 1 PROCEDURE IT WAS UNKNOWN IF OR HOW THE CASE WAS COMPLETED. 3 PROCEDURES HAD NO DELAY, 7 HAD LESSTHAN AN HOUR OF DELAY, 1 HAD A DELAY GREATER THAN 1 HOUR, AND IN 1 PROCEDURE IT WAS UNKNOWN IF OR HOW MUCH DELAY THERE WAS. 6 OF THESE PROCEDURES INVOLVED NO REVISIONS, 3 HAD INTRAOPERATIVE REVISIONS, 2 HAD POST-OPERATIVE REVISION, AND FOR 1 PROCEDURE IT WAS UNKNOWN IF A REVISION OCCURRED. 11 OF THE PROCEDURES INVOLVED IMPRECISIONS. IN THESE PROCEDURES, THERE WERE 2 IMPRECISIONS THAT WERE 3MM OFF, 1 THAT WAS 4MM OFF, 1 THAT WAS 8 MM OFF, 1 THAT WAS AT LEAST 9MM OFF, AND 7 THAT WERE DEVIATED BY AN UNKNOWN AMOUNT OR NOT APPLICABLE WHEN IT CAME TO THE AMOUNT OF DEVIATION. DIRECTIONALLY, 3 OF THESE IMPRECISIONS WERE SUPERIOR, 3 WERE LATERAL, 3 WERE MEDIAL, AND FOR 3 THE DIRECTION WAS UNKNOWN. ONE PROCEDURE HAD A REGISTRATION ERROR. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458864 RENAISSANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MAZOR ROBOTICS LTD TPL0038

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown