BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAZOR X SYSTEM

    MDR report key: 21719573 · Received March 28, 2025

    Report

    Report Number
    3005075696-2025-00239
    Event Type
    Death
    Date Received
    March 28, 2025
    Date of Event
    February 25, 2025
    Report Date
    March 28, 2025
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    OLO
    PMA / PMN Number
    K182077
    Adverse Event
    Yes
    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 PATIENT CODES WERE APPLIED. BELOW LISTED WHAT EACH CORRELATES TO. E2401 - DEATH AND ALLEGED CLINICAL INJURIES E2403 - EVENTS WITH NO PATIENT HARM OR THAT OCCURRED OUTSIDE OF A PROCEDURE. MULTIPLE DEVICE CODES WERE APPLIED. BELOW LISTED WHAT EACH CORRELATES TO. A0908 - INACCURACY A051205 - DEVICE COLLISION A110201 - SOFTWARE UNRESPONSIVENESS A23 - REGISTRATION ERROR, COMPUTER HARDWARE FAILURE, AND THE UNKNOWN ADVERSE EVENT. 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 241 EVENTS WERE DOCUMENTED WHILE USING A GUIDANCE SYSTEM. OF THESE EVENTS, 2 OCCURRED OUTSIDE OF THE OPERATING ROOM(OR), 2 IN THE OR BEFORE ANESTHESIA, 12 IN THE OR AFTER ANESTHESIA, 195 AFTER THE INCISION WAS MADE, AND 30 WERE POSTOPERATIVE. IF THE EVENT OCCURRED DURING A PROCEDURE, THE PROCEDURE WAS A SPINAL PROCEDURE. OF THE EVENTS THAT OCCURRED DURING A PROCEDURE, 19 CONTINUED WITHOUT CORRECTION, 82 AMELIORATED, 14 CONTINUED WITH NAVIGATION ONLY, 4 ABORTED PROCEDURE, 86 CONTINUED WITH FLUOROSCOPY, AND IN 15 IT WAS UNKNOWN HOW THE CASE WAS COMPLETED. IT WAS NOTED 37 EVENTS HAD NO DELAY, 1 HAD LESS THAN 30 MINUTES DELAY, 136 HAD LESS THAN 1 HOUR OF DELAY, 34 HAD GREATER THAN 1 HOUR OF DELAY, AND 33 IT WAS UNKNOWN HOW MUCH DELAY THERE WAS. THE LITERATURE ALSO DOCUMENTS 54 EVENTS DID NOT NEED REVISION, IN 131 THERE WAS AN INTRAOPERATIVE REVISION, IN 35 THERE WAS A POST-OPERATIVE REVISION, IN 5 THE PROCEDURE WAS RESCHEDULED, AND IN 16 IT WAS UNKNOWN IF ANY CORRECTION WAS PERFORMED. IN ONE EVENT A DEATH WAS DOCUMENTED. THERE WERE 23 EVENTS TO REPORT CLINICALLY SIGNIFICANT INJURY AND 12 REPORTED CLINICALLY INSIGNIFICANT INJURY. THERE WERE 206 IMPRECISIONS. 1 IMPRECISION WAS 1MM OFF, 5 WERE 2MM OFF, 20 WERE 3MM OFF, 19 WERE 4MM OFF, 17 WERE 5MM OFF, 2 WERE 6MM OFF, 6 WERE 7MM OFF, 1 WAS 8MM OFF, 13 WERE AT LEAST 9MM OFF, AND FOR 157 IT WAS NOT APPLICABLE OR UNKNOWN WHAT THE IMPRECISION AMOUNT WAS. OF THESE IMPRECISIONS, 18 WERE SUPERIOR, 65 WERE LATERAL, 18 WERE INFERIOR, 101 WERE MEDIAL, AND FOR 39 THE DIRECTION WAS UNKNOWN. THERE WAS 1 DEVICE COLLISION, 1 REGISTRATION ERROR, 19 EVENTS OF SOFTWARE UNRESPONSIVENESS, 5 MECHANICAL DEFORMATIONS, 2 COMPUTER HARDWARE FAILURES, AND 1 UNKNOWN ADVERSE EVENT. IN 202 EVENTS THERE WAS NO INJURY AND IN 3 EVENTS IT WAS UNKNOWN IF THERE WAS ANY IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2613085 MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAZOR ROBOTICS LTD TPL0059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| R| O